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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 2020 | K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators Ortho Clinical Diagnostics | PMT |
| Jul 16, 2018 | K181002 | Atellica IM BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics, Inc. | PMT |
| Jun 28, 2016 | K160911 | VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc. | PMT |
| Jun 13, 2016 | K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 Roche Diagnostics | PMT |
| Feb 20, 2016 | DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTOR Brahms GmbH, DE | PMT |
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