K983696 is an FDA 510(k) clearance for the ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 5, 1999, 107 days after receiving the submission on October 21, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K983696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1998 |
| Decision Date | February 05, 1999 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MID — System, Test, Anticardiolipin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |