K040431 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2. This device is classified as a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II - Special Controls, product code DAO).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 10, 2004, 20 days after receiving the submission on February 19, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K040431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2004 |
| Decision Date | March 10, 2004 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |