K946216 is an FDA 510(k) clearance for the CARDIOLIPIN A EIA TEST SYSTEM. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on January 24, 1996, 399 days after receiving the submission on December 21, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K946216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1994 |
| Decision Date | January 24, 1996 |
| Days to Decision | 399 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MID — System, Test, Anticardiolipin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |