The following data is part of a premarket notification filed by Sqi Diagnostics Systems Inc. with the FDA for Ig_plex Celiac Dgp Panel.
| Device ID | K140691 |
| 510k Number | K140691 |
| Device Name: | IG_PLEX CELIAC DGP PANEL |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | SQI DIAGNOSTICS SYSTEMS INC. 36 Meteor Dr. Toronto, On, CA M9w 1a4 |
| Contact | Kate Smith |
| Correspondent | Kate Smith SQI DIAGNOSTICS SYSTEMS INC. 36 Meteor Dr. Toronto, On, CA M9w 1a4 |
| Product Code | MVM |
| Subsequent Product Code | MST |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-19 |
| Decision Date | 2014-11-06 |
| Summary: | summary |