The following data is part of a De Novo classification by B.r.a.h.m.s Gmbh with the FDA for B.r.a.h.m.s Pct Sensitive Kryptor.
DeNovo ID | DEN150009 |
Device Name: | B.R.A.H.M.S PCT Sensitive KRYPTOR |
Classification | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
Applicant | B.R.A.H.M.S GMBH neuendorfstr. 25 Hennigsdorf, DE 16761 |
Contact | Bernhard Ciommer |
Product Code | PMT |
CFR Regulation Number | 866.3215 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Microbiology |
Classification Advisory | Microbiology |
Type | Direct |
Date Received | 2015-03-04 |
Decision Date | 2016-02-20 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260157638990 | DEN150009 | 000 |
04260157632875 | DEN150009 | 000 |
04260157632882 | DEN150009 | 000 |
04260157633216 | DEN150009 | 000 |
04260157633223 | DEN150009 | 000 |
04260157633230 | DEN150009 | 000 |
04260157633247 | DEN150009 | 000 |
04260157638259 | DEN150009 | 000 |
04260157638976 | DEN150009 | 000 |
04260157638983 | DEN150009 | 000 |
04260157630949 | DEN150009 | 000 |