K192916 is an FDA 510(k) clearance for the NOVA Lite DAPI dsDNA Crithidia luciliae Kit. This device is classified as a Anti-dna Indirect Immunofluorescent Solid Phase (Class II - Special Controls, product code KTL).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 11, 2020, 423 days after receiving the submission on October 15, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K192916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2019 |
| Decision Date | December 11, 2020 |
| Days to Decision | 423 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | KTL — Anti-dna Indirect Immunofluorescent Solid Phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |