The following data is part of a De Novo classification by Streck, Inc. with the FDA for Cell-free Dna Bct.
DeNovo ID | DEN200001 |
Device Name: | Cell-Free DNA BCT |
Classification | Blood Collection Device For Cell-free Nucleic Acid |
Applicant | Streck, Inc. 7002 S. 109th Street La Vista, NE 68128 |
Contact | Deborah Kipp |
Product Code | QMA |
CFR Regulation Number | 862.1676 [🔎] |
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 | Clinical Chemistry |
Classification Advisory | Clinical Chemistry |
Type | Direct |
Date Received | 2020-01-10 |
Decision Date | 2020-08-07 |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844509002253 | DEN200001 | 000 |