K101203 is an FDA 510(k) clearance for the TINA-QUANT ALBUMIN GEN 2. This device is classified as a Albumin, Antigen, Antiserum, Control (Class II - Special Controls, product code DCF).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 10, 2010, 134 days after receiving the submission on April 29, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5040.
| 510(k) Number | K101203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2010 |
| Decision Date | September 10, 2010 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DCF — Albumin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5040 |