K981644 is an FDA 510(k) clearance for the BINDAZYME ANTIGLIADIN IGG. 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 September 3, 1998, 118 days after receiving the submission on May 8, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K981644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1998 |
| Decision Date | September 03, 1998 |
| Days to Decision | 118 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 |