DEN130002 is an FDA 510(k) submission for the TINA-QUANT HBA1C GEN. 2 TEST SYSTEM. This device is classified as a Hemoglobin A1c Test System (Class II - Special Controls, product code PDJ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Not Cleared (DENG) decision on May 23, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1373. Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes..
| 510(k) Number | DEN130002 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 25, 2013 |
| Decision Date | May 23, 2013 |
| Days to Decision | 59 days |
| Submission Type | Post-NSE |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | PDJ — Hemoglobin A1c Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1373 |
| Definition | Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes. |