The following data is part of a premarket notification filed by Sqi Diagnostics Systems with the FDA for Igx Plex Rheumatoid Arthritis (ra) Assay And Sqidworks Diagnostics Platform.
| Device ID | K083080 |
| 510k Number | K083080 |
| Device Name: | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| Subsequent Product Code | NHX |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-16 |
| Decision Date | 2009-10-29 |
| Summary: | summary |