TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
FDA 510(k) clearance K072714 · decided 2008-04-18
Clearance details
- K-number
- K072714
- Device name
- TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-25
- Decision date
- 2008-04-18
- Days to decision
- 206 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640 recall (Z-0395-2017) | Roche Diagnostics Operations, Inc. | 2016-11-11 |
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