Para 4
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials each of low, normal & high…
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials each of low, normal & high levels.
3manufacturers in China registered for this device type
17catalogue numbers in this listing
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Streck LLC, United States |
|---|---|
| FDA product code | JPK |
| Device type | Mixture, Hematology Quality Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K842017 |
| Record published | 2016-09-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
| Sizes | Total volume 1.5 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 215428 | Total Volume 1.5 ml | In distribution |
| 215418 | Total Volume 1.5 ml | In distribution |
| 215409 | Total Volume 1.5 ml | In distribution |
| 215408 | Total Volume 1.5 ml | In distribution |
| 215426 | Total Volume 1.5 ml | In distribution |
| 215115 | Total Volume 1.5 ml | In distribution |
| 215103 | Total Volume 1.5 ml | In distribution |
| 215412 | Total Volume 1.5 ml | In distribution |
| 215403 | Total Volume 1.5 ml | In distribution |
| 215107 | Total Volume 1.5 ml | In distribution |
| 215112 | Total Volume 1.5 ml | In distribution |
| 215406 | Total Volume 1.5 ml | In distribution |
| 215436 | Total Volume 1.5 ml | In distribution |
| 215106 | Total Volume 1.5 ml | In distribution |
| 215108 | Total Volume 1.5 ml | In distribution |
| 215416 | Total Volume 1.5 ml | In distribution |
| 215110 | Total Volume 1.5 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 140 |
| Liquichek | Bio-Rad Laboratories Inc. | 34 |
| Drew Scientific | Drew Scientific, Ltd. | 15 |
| CVA | Streck LLC | 9 |
| Stat Profile | Nova Biomedical Corporation | 8 |
| Coulter 5C | Beckman Coulter, Inc. | 8 |
| Retic-Chex II | Streck LLC | 7 |
| BD Multi-Check | Becton, Dickinson AND Company | 6 |
| Cell-Chex Auto | Streck LLC | 6 |
| Coulter 4C-ES | Beckman Coulter, Inc. | 5 |
| Trinity Biotech | Primus Corp. | 4 |
| Difftrol | Horiba Instruments Incorporated | 4 |
Showing 12 of 97. All products under Mixture, Hematology Quality Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160588 | 2016-12-22 |
| K160590 | 2016-12-22 |
| K160586 | 2016-12-22 |
| K141964 | 2014-12-05 |
| K141957 | 2014-12-05 |
| K120742 | 2012-10-19 |
| K120744 | 2012-10-19 |
| K090201 | 2009-03-27 |
| K070199 | 2007-02-23 |
| K063218 | 2006-12-14 |
| K053362 | 2006-01-13 |
| K051706 | 2005-08-17 |
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.