K012359 is an FDA 510(k) clearance for the TINA-QUANT COMPLEMENT C4 TEST SYSTEM. This device is classified as a Complement C4, Antigen, Antiserum, Control (Class II - Special Controls, product code DBI).
Submitted by Roche Diagnostics Corp. (Indianapolis,, US). The FDA issued a Cleared decision on November 29, 2001, 127 days after receiving the submission on July 25, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K012359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2001 |
| Decision Date | November 29, 2001 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBI — Complement C4, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |