K081674 is an FDA 510(k) clearance for the BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT. This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on October 15, 2008, 120 days after receiving the submission on June 17, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K081674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2008 |
| Decision Date | October 15, 2008 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |