K102425 is an FDA 510(k) clearance for the ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 12, 2011, 474 days after receiving the submission on August 25, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K102425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2010 |
| Decision Date | December 12, 2011 |
| Days to Decision | 474 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 |