K213403 is an FDA 510(k) clearance for the Aptiva CTD Essential Reagent. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 29, 2023, 711 days after receiving the submission on October 18, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K213403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2021 |
| Decision Date | September 29, 2023 |
| Days to Decision | 711 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |