The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Alt/gpt Reagent Kit.
| Device ID | K921016 |
| 510k Number | K921016 |
| Device Name: | SYNERMED ALT/GPT REAGENT KIT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091712 | K921016 | 000 |
| 05060500090227 | K921016 | 000 |
| 05060500090210 | K921016 | 000 |
| 05060500090203 | K921016 | 000 |
| 05060500090197 | K921016 | 000 |
| 05060500090180 | K921016 | 000 |
| 05060500090173 | K921016 | 000 |