The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Nova Lite Dapi Anca Ethanol Kit, Nova Lite Dapi Anca Formalin Kit.
| Device ID | K161258 |
| 510k Number | K161258 |
| Device Name: | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-04 |
| Decision Date | 2017-02-03 |
| Summary: | summary |