Coulter 5c
COULTER 5C Cell Control
3manufacturers in China registered for this device type
8catalogue numbers in this listing
10510(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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JPK |
| Device type | Mixture, Hematology Quality Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2025-11-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7547011 | Withdrawn | |
| 7547116 | Withdrawn | |
| 7547124 | Withdrawn | |
| 7547001 | Withdrawn | |
| 7547117 | Withdrawn | |
| 624506 | Withdrawn | |
| 7547199 | Withdrawn | |
| 7547010 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 140 |
| Liquichek | Bio-Rad Laboratories Inc. | 34 |
| Para 4 | Streck LLC | 17 |
| Drew Scientific | Drew Scientific, Ltd. | 15 |
| CVA | Streck LLC | 9 |
| Stat Profile | Nova Biomedical Corporation | 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 |
|---|---|
| K100790 | 2010-12-21 |
| K100607 | 2010-11-18 |
| K082162 | 2009-02-03 |
| K081822 | 2009-01-21 |
| K081641 | 2009-01-16 |
| K061064 | 2006-05-17 |
| K060464 | 2006-03-28 |
| K013842 | 2001-12-13 |
| K010066 | 2001-02-07 |
| K010064 | 2001-02-07 |
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.