The following data is part of a premarket notification filed by Sqi Diagnostics Systems with the FDA for Igx Plex Celiac Qualitative Assay.
| Device ID | K102490 |
| 510k Number | K102490 |
| Device Name: | IGX PLEX CELIAC QUALITATIVE ASSAY |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | SQI DIAGNOSTICS SYSTEMS 36 METEOR DR. Toronto, Ontario, CA M9w 1a4 |
| Contact | Kate Smith |
| Correspondent | Kate Smith SQI DIAGNOSTICS SYSTEMS 36 METEOR DR. Toronto, Ontario, CA M9w 1a4 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-31 |
| Decision Date | 2011-06-02 |
| Summary: | summary |