Panels › Clinical Chemistry › Product code JKR · Class 2
Radioimmunoassay, Calcitonin
Regulation 862.1140
1510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JKR
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 4 | 0 |
| Nichols Institute Diagnostics | 3 | 0 |
| Diagnostic Products Corp. | 2 | 0 |
| Roche Diagnostics | 2 | 0 |
| Scantibodies Laboratory, Inc. | 2 | 0 |
| Axis-Shield Diagnostics Limited | 1 | 0 |
| Biomerica | 0 | 1 |
| Cambridge Nuclear Radiopharmaceutical | 1 | 0 |
| Cis-Us, Inc. | 1 | 0 |
| Endocrine Associates, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Biomerica Calcitonin ELISA Kit, Code No. 7024, 7024BU.
Intended use of this product is the quantitative determination of Calcitonin in human serum. Terminated |
JKR | K982491 |
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