The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Albumin Reagent Kit.
| Device ID | K903543 |
| 510k Number | K903543 |
| Device Name: | SYNERMED ALBUMIN REAGENT KIT |
| Classification | Bromcresol Green Dye-binding, Albumin |
| 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 | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-07 |
| Decision Date | 1990-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091682 | K903543 | 000 |
| 05060500090067 | K903543 | 000 |
| 05060500090050 | K903543 | 000 |
| 05060500090043 | K903543 | 000 |
| 05060500090036 | K903543 | 000 |
| 05060500090029 | K903543 | 000 |