The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Plex Celiac Iga Profile.
| Device ID | K063818 |
| 510k Number | K063818 |
| Device Name: | QUANTA PLEX CELIAC IGA PROFILE |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers 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 | 2006-12-22 |
| Decision Date | 2007-06-20 |