The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Serum Iron-600 Reagent Kit.
| Device ID | K912912 |
| 510k Number | K912912 |
| Device Name: | SYNERMED SERUM IRON-600 REAGENT KIT |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| 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 | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1991-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091903 | K912912 | 000 |
| 05060500091033 | K912912 | 000 |
| 05060500091026 | K912912 | 000 |
| 05060500091019 | K912912 | 000 |
| 05060500091002 | K912912 | 000 |
| 05060500090999 | K912912 | 000 |
| 05060500090982 | K912912 | 000 |