Immuno-Trol Cells
Catalogue number 6607077, listed by Beckman Coulter, Inc., United States, under Mixture, Hematology Quality Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 | 2023-06-19 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6607077 | 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 |
| Para 4 | Streck LLC | 17 |
| 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 |
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.