The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Aptiva Celiac Disease Igg Reagent.
| Device ID | K200230 |
| 510k Number | K200230 |
| Device Name: | Aptiva Celiac Disease IgG Reagent |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131 -1638 |
| Contact | Andrea Seaman |
| Correspondent | Andrea Seaman Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego, CA 92131 -1638 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-30 |
| Decision Date | 2021-08-26 |