K984516 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET. 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 January 11, 1999, 24 days after receiving the submission on December 18, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K984516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 24 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 |