CardioChek
CardioChek 15Lipid/15Glucose
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | LBR |
| Device type | Ldl & Vldl Precipitation, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| 510(k) | K022898 |
| Record published | 2017-01-05 |
| Record revised | 2023-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight.; Special storage condition: Keep dry.; Storage environment temperature 20 to 30 °C; Storage environment temperature 68 to 86 °F |
| Packaging | Pack of 15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5700414 | 15 | In distribution | |
| 5700412 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| LDL-Cholesterol Gen.3 | Roche Diagnostics Gmbh | 3 |
| L-Type HDL-C Reagent 2 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix | Teco Diagnostics | 2 |
| N-geneous LDL Cholesterol Reagent (R1) | Sekisui Diagnostics, LLC | 2 |
| N-geneous LDL Cholesterol Reagent (R2) | Sekisui Diagnostics, LLC | 2 |
| PTS Panels® HDL Cholesterol Test Strips | Polymer Technology Systems | 2 |
| Teco Diagnostics HDL Cholesterol Reagent Set | Teco Diagnostics | 2 |
| L-Type HDL-C Reagent 1 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616 | Carolina Liquid Chemistries | 1 |
| Curo L5 | KPI Healthcare, Inc. | 1 |
Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 total | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 total | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 total | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-01-16 | Class II | Device Design | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bu | 67643 total | 2020-06-24 |
| Polymer Technology Systems | 510(k) number | 2009-06-05 | Not classified | Nonconforming Material/Component | Exhibits under-recovery of all analytes. | Not available. | 2010-10-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.