FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
K Number: DEN130002
·
Decision May 23, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
183
Review Days
59
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Basic Information
- Device Name
- TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
- K Number
- DEN130002
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Roche Diagnostics
- Date Received
- March 25, 2013
- Decision Date
- May 23, 2013
- Product Code
- PDJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | FDA class 2 | Clinical Chemistry |
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