The following data is part of a premarket notification filed by Synermed Intl., Inc. with the FDA for Synermed Creatinine Reagent Kit.
| Device ID | K974909 |
| 510k Number | K974909 |
| Device Name: | SYNERMED CREATININE REAGENT KIT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | SYNERMED INTL., INC. 1688 50TH AVE. Lachine, Quebec, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED INTL., INC. 1688 50TH AVE. Lachine, Quebec, CA H8t 2v5 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091873 | K974909 | 000 |
| 05060500090784 | K974909 | 000 |
| 05060500090777 | K974909 | 000 |
| 05060500090760 | K974909 | 000 |
| 05060500090753 | K974909 | 000 |
| 05060500090746 | K974909 | 000 |
| 05060500090739 | K974909 | 000 |