The following data is part of a De Novo classification by Baebies, Inc. with the FDA for Seeker System.
| DeNovo ID | DEN150035 |
| Device Name: | SEEKER System |
| Classification | Alpha-d-galactosidase A (gla) Newborn Screening Test System |
| Applicant | Baebies, Inc. 615 Davis Drive, po Box 14403 Durham, NC 27709 |
| Contact | Vamsee Pamula |
| Product Code | PQW |
| CFR Regulation Number | 862.1488 [🔎] |
| 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 | 2015-08-05 |
| Decision Date | 2017-02-03 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819704020258 | DEN150035 | 000 |
| 00819704020012 | DEN150035 | 000 |
| 00819704020029 | DEN150035 | 000 |
| 00819704020081 | DEN150035 | 000 |
| 00819704020098 | DEN150035 | 000 |
| 00819704020104 | DEN150035 | 000 |
| 00819704020111 | DEN150035 | 000 |
| 00819704020128 | DEN150035 | 000 |
| 00819704020135 | DEN150035 | 000 |
| 00819704020142 | DEN150035 | 000 |
| 00819704020159 | DEN150035 | 000 |
| 00819704020166 | DEN150035 | 000 |
| 00819704020173 | DEN150035 | 000 |
| 00819704020180 | DEN150035 | 000 |
| 00819704020227 | DEN150035 | 000 |
| 00819704020234 | DEN150035 | 000 |
| 00819704020241 | DEN150035 | 000 |
| 00819704020005 | DEN150035 | 000 |