The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Nova Lite Dapi Ana Kit.
| Device ID | K150155 |
| 510k Number | K150155 |
| Device Name: | NOVA Lite DAPI ANA Kit |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| 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 | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-23 |
| Decision Date | 2015-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950621843 | K150155 | 000 |