The following data is part of a De Novo classification by Asuragen, Inc. with the FDA for Quantidex Qpcr Bcr-abl Is Kit.
DeNovo ID | DEN160003 |
Device Name: | Quantidex QPCR BCR-ABL IS Kit |
Classification | Bcr/abl1 Monitoring Test |
Applicant | ASURAGEN, INC. 2150 Woodward, Suite 100 Austin, TX 78744 |
Contact | Fayyaz Memon |
Product Code | OYX |
CFR Regulation Number | 866.6060 [🔎] |
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 | Molecular Genetics |
Classification Advisory | Molecular Genetics |
Type | Direct |
Date Received | 2016-01-19 |
Decision Date | 2016-07-22 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863840000223 | DEN160003 | 000 |