The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ir 500 Chemistry Analyzer.
| Device ID | K935662 |
| 510k Number | K935662 |
| Device Name: | SYNERMED IR 500 CHEMISTRY ANALYZER |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Product Code | JIQ |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CJY |
| Subsequent Product Code | JJF |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500090005 | K935662 | 000 |