The following data is part of a De Novo classification by Ab Sciex Llc with the FDA for Vitamin D 200m Assay For The Topaz System.
DeNovo ID | DEN170019 |
Device Name: | Vitamin D 200M Assay For The Topaz System |
Classification | 25-oh-vitamin D Mass Spectrometry Test System |
Applicant | AB SCIEX LLC 500 Old Connecticut Path Framingham, MA 01701 |
Contact | Shilpa Sharma |
Product Code | PSL |
CFR Regulation Number | 862.1840 [🔎] |
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 | Post-NSE |
Date Received | 2017-03-20 |
Decision Date | 2017-05-18 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10842365100219 | DEN170019 | 000 |
00842365100090 | DEN170019 | 000 |
00842365100106 | DEN170019 | 000 |
00842365100113 | DEN170019 | 000 |
10842365100127 | DEN170019 | 000 |
00842365100137 | DEN170019 | 000 |
10842365100141 | DEN170019 | 000 |
10842365100158 | DEN170019 | 000 |
10842365100165 | DEN170019 | 000 |
00842365100175 | DEN170019 | 000 |
00842365100182 | DEN170019 | 000 |
00842365100199 | DEN170019 | 000 |
00842365100205 | DEN170019 | 000 |
00842365100021 | DEN170019 | 000 |