K951187 is an FDA 510(k) clearance for the VARELISA CARDIOLIPIN ABS SCREEN. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on October 2, 1995, 200 days after receiving the submission on March 16, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K951187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1995 |
| Decision Date | October 02, 1995 |
| Days to Decision | 200 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 |