The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ast/got Reagent Kit.
| Device ID | K915555 |
| 510k Number | K915555 |
| Device Name: | SYNERMED AST/GOT REAGENT KIT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-11 |
| Decision Date | 1992-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091729 | K915555 | 000 |
| 05060500090289 | K915555 | 000 |
| 05060500090272 | K915555 | 000 |
| 05060500090265 | K915555 | 000 |
| 05060500090258 | K915555 | 000 |
| 05060500090241 | K915555 | 000 |
| 05060500090234 | K915555 | 000 |