The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Amylase Reagent Kit.
| Device ID | K941091 |
| 510k Number | K941091 |
| Device Name: | SYNERMED AMYLASE REAGENT KIT |
| Classification | Catalytic Methods, Amylase |
| 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 | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-08 |
| Decision Date | 1994-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091705 | K941091 | 000 |
| 05060500090166 | K941091 | 000 |
| 05060500090159 | K941091 | 000 |
| 05060500090142 | K941091 | 000 |
| 05060500090135 | K941091 | 000 |
| 05060500090128 | K941091 | 000 |