K964446 is an FDA 510(k) clearance for the MYELOPEROXIDASE ELISA TEST SYSTEM. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 10, 1997, 155 days after receiving the submission on November 6, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K964446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1996 |
| Decision Date | April 10, 1997 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |