FDA.reportPublic FDA data

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