De Novo DEN130002
- Device
- TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
- Contact
- susan hollandbeck
- De Novo number
- DEN130002
- Product code
- PDJ
- Regulation
- 862.1373
- Classification name
- hemoglobin a1c test system
- Decision
- granted (DENG)
- Decision date
- 2013-05-23
- Date received
- 2013-03-25
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PDJ
- Device name
- Hemoglobin A1c Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1373
- Implant
- N
- Life sustain/support
- N