The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Celiac Screen (tissue Transglutaminase/gliadin) Elisa.
| Device ID | K984137 |
| 510k Number | K984137 |
| Device Name: | QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-01-28 |