K993612 is an FDA 510(k) clearance for the BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA. This device is classified as a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II - Special Controls, product code MVM).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on December 21, 1999, 57 days after receiving the submission on October 25, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K993612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1999 |
| Decision Date | December 21, 1999 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |