The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ggt Reagent Kit.
| Device ID | K931958 |
| 510k Number | K931958 |
| Device Name: | SYNERMED GGT REAGENT KIT |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| 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 | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-20 |
| Decision Date | 1993-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091880 | K931958 | 000 |
| 05060500090913 | K931958 | 000 |
| 05060500090906 | K931958 | 000 |
| 05060500090890 | K931958 | 000 |
| 05060500090883 | K931958 | 000 |
| 05060500090876 | K931958 | 000 |