K001127 is an FDA 510(k) clearance for the ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on August 30, 2000, 149 days after receiving the submission on April 3, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K001127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2000 |
| Decision Date | August 30, 2000 |
| Days to Decision | 149 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 |