The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Calcium Reagent Kit.
| Device ID | K953395 |
| 510k Number | K953395 |
| Device Name: | SYNERMED CALCIUM REAGENT KIT |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-18 |
| Decision Date | 1995-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091835 | K953395 | 000 |
| 05060500090500 | K953395 | 000 |
| 05060500090494 | K953395 | 000 |
| 05060500090487 | K953395 | 000 |
| 05060500090470 | K953395 | 000 |
| 05060500090463 | K953395 | 000 |