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 |