510(k) DEN150035
- Device
- SEEKER System
- Applicant
- Baebies, Inc.
- 510(k) number
- DEN150035
- Product code
- PQW
- Decision
- Unknown (DENG)
- Decision date
- 2017-02-03
- Date received
- 2015-08-05
- Regulation
- 862.1488
- Classification name
- Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Vamsee Pamula
- Address
- 615 Davis Dr., P.O. Box 14403 Durham NC US 27709 27709
FDA Registration Numbers#
- 3042250641
- 8043909
- 3011240982
Source Documents#
510(k) summary PDF not indicated by FDA