B.R.A.H.M.S PCT Sensitive KRYPTOR

Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens

B.R.A.H.M.S GMBH

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.

Pre-market Notification Details

DeNovo IDDEN150009
Device Name:B.R.A.H.M.S PCT Sensitive KRYPTOR
ClassificationDevice To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
Applicant B.R.A.H.M.S GMBH neuendorfstr. 25 Hennigsdorf,  DE 16761
ContactBernhard Ciommer
Product CodePMT  
CFR Regulation Number866.3215 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2015-03-04
Decision Date2016-02-20
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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