K161258 is an FDA 510(k) clearance for the NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 3, 2017, 275 days after receiving the submission on May 4, 2016.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K161258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2016 |
| Decision Date | February 03, 2017 |
| Days to Decision | 275 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 |