The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Nova Lite Dapi Dsdna Crithidia Luciliae Kit.
| Device ID | K192916 |
| 510k Number | K192916 |
| Device Name: | NOVA Lite DAPI DsDNA Crithidia Luciliae Kit |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | Inova Diagnostics, Inc. 9900 Old Grove Rd San Diego, CA 92131 |
| Contact | Carolina Auza |
| Correspondent | Carolina Auza Inova Diagnostics, Inc. 9900 Old Grove Rd San Diego, CA 92131 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2020-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951056538 | K192916 | 000 |