Panels › Microbiology › Product code PMT · Class 2
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Regulation 866.3215
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PMT
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 1 | 1 |
| bioMerieux, Inc. | 1 | 0 |
| Brahms GmbH | 1 | 0 |
| Ortho Clinical Diagnostics | 1 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2017 | Roche Diagnostics Corporation Elecsys BRAHMS PCT
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin). Terminated |
PMT | K160729 |
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