DEN150035 is an FDA 510(k) submission for the SEEKER System. This device is classified as a Alpha-d-galactosidase A (gla) Newborn Screening Test System (Class II - Special Controls, product code PQW).
Submitted by Baebies, Inc. (Durham, US). The FDA issued a Not Cleared (DENG) decision on February 3, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1488. For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens..
| 510(k) Number | DEN150035 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 05, 2015 |
| Decision Date | February 03, 2017 |
| Days to Decision | 548 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | PQW - Alpha-d-galactosidase A (gla) Newborn Screening Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1488 |
| Definition | For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens. |