The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Chloride Reagent Kit.
| Device ID | K903103 |
| 510k Number | K903103 |
| Device Name: | SYNERMED CHLORIDE REAGENT KIT |
| Classification | Acid, Phosphoric-tungstic (spectrophotometric), Chloride |
| 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 | CHG |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-13 |
| Decision Date | 1990-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091842 | K903103 | 000 |
| 05060500090562 | K903103 | 000 |
| 05060500090555 | K903103 | 000 |
| 05060500090548 | K903103 | 000 |
| 05060500090531 | K903103 | 000 |
| 05060500090524 | K903103 | 000 |
| 05060500090517 | K903103 | 000 |