510(k) DEN150035
DEN150035 is an FDA 510(k) premarket notification submitted by Baebies, Inc. for the device "SEEKER System". The FDA issued a decision of De Novo Granted on February 3, 2017. The device falls under product code PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System), a Class II device regulated under 21 CFR 862.1488. Baebies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 3, 2017
- Date Received
- August 5, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
- Device Class
- Class II
- Regulation Number
- 862.1488
- Review Panel
- CH
- Submission Type
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.