K984347 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F. 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 17, 1998, 13 days after receiving the submission on December 4, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K984347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1998 |
| Decision Date | December 17, 1998 |
| Days to Decision | 13 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 |