CardioChek
CardioChek Plus Analyzer
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Shandong (1), Guangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Eaglenos Sciences, Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Medicalsystem Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | CHH |
| Device type | Enzymatic Esterase–Oxidase, Cholesterol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1175 |
| 510(k) | K140068 |
| Record published | 2017-01-05 |
| Record revised | 2023-10-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Storage environment temperature 10 to 40 °C; Storage environment humidity 20 to 80 % RH; Special storage condition: Keep away from sunlight.; Special storage condition: Keep dry.; Storage environment temperature 50 to 104 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5700411 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fora | Fora Care Inc. | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| JAS Diagnostics | Drew Scientific, Ltd. | 7 |
| Standard™ LipidoCare Lipid Test Strip – Lipid Profile | SD Biosensor, Inc. | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 4 |
| Carolina Liquid Chemistries Corp.® Cholesterol Reagent KIT BL211 | Carolina Liquid Chemistries | 4 |
| Cholesterol Gen.2 | Roche Diagnostics Gmbh | 3 |
| AU | Beckman Coulter, Inc. | 3 |
| Pointe Scientific, Inc. Cholesterol | Horiba Instruments Incorporated | 3 |
| Cholestech LDX™ | Alere San Diego, Inc. | 3 |
| Pointe Scientific Cholesterol (Liquid) | Horiba Instruments Incorporated | 3 |
Showing 12 of 77. All products under Enzymatic Esterase–Oxidase, Cholesterol
Recalls Naming This Product
4 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 |
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.