The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ise Reagents.
| Device ID | K941400 |
| 510k Number | K941400 |
| Device Name: | SYNERMED ISE REAGENTS |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1994-04-26 |