K050113 is an FDA 510(k) clearance for the TINA-QUANT IGG GEN.2. This device is classified as a Igg, Antigen, Antiserum, Control (Class II - Special Controls, product code DEW).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 8, 2005, 21 days after receiving the submission on January 18, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K050113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2005 |
| Decision Date | February 08, 2005 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DEW — Igg, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |