K193604 is an FDA 510(k) clearance for the Aptiva Celiac Disease IgA Reagent. This device is classified as a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II - Special Controls, product code MVM).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 16, 2021, 541 days after receiving the submission on December 23, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K193604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | June 16, 2021 |
| Days to Decision | 541 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |