K150155 is an FDA 510(k) clearance for the NOVA Lite DAPI ANA Kit. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DHN).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 8, 2015, 75 days after receiving the submission on January 23, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K150155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2015 |
| Decision Date | April 08, 2015 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |