K983390 is an FDA 510(k) clearance for the IS-ANTI-MPO IGG ELISA TEST SYSTEM. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on November 18, 1998, 54 days after receiving the submission on September 25, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K983390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1998 |
| Decision Date | November 18, 1998 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |