K991801 is an FDA 510(k) clearance for the BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT. This device is classified as a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II - Special Controls, product code MSV).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on May 5, 2000, 345 days after receiving the submission on May 26, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K991801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1999 |
| Decision Date | May 05, 2000 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |