K971784 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA 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 July 23, 1997, 70 days after receiving the submission on May 14, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K971784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1997 |
| Decision Date | July 23, 1997 |
| Days to Decision | 70 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 |