The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ir 200 Chemistry Analyzer.
| Device ID | K971491 |
| 510k Number | K971491 |
| Device Name: | SYNERMED IR 200 CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| 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 | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-24 |
| Decision Date | 1997-06-26 |