Cell-Free DNA BCT

Blood Collection Device For Cell-free Nucleic Acid

Streck, Inc.

The following data is part of a De Novo classification by Streck, Inc. with the FDA for Cell-free Dna Bct.

Pre-market Notification Details

DeNovo IDDEN200001
Device Name:Cell-Free DNA BCT
ClassificationBlood Collection Device For Cell-free Nucleic Acid
Applicant Streck, Inc. 7002 S. 109th Street La Vista,  NE  68128
ContactDeborah Kipp
Product CodeQMA  
CFR Regulation Number862.1676 [🔎]
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 BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
TypeDirect
Date Received2020-01-10
Decision Date2020-08-07
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844509002253 DEN200001 000

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