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De Novo DEN150035
- Device
- SEEKER System
- Contact
- vamsee pamula
- De Novo number
- DEN150035
- Product code
- PQW
- Regulation
- 862.1488
- Classification name
- alpha-d-galactosidase a (gla) newborn screening test system
- Decision
- granted (DENG)
- Decision date
- 2017-02-03
- Date received
- 2015-08-05
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- PQW
- Device name
- Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1488
- Implant
- N
- Life sustain/support
- N