The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Uibc Reagent Kit.
| Device ID | K922784 |
| 510k Number | K922784 |
| Device Name: | SYNERMED UIBC REAGENT KIT |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1992-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091965 | K922784 | 000 |
| 05060500091460 | K922784 | 000 |
| 05060500091453 | K922784 | 000 |
| 05060500091446 | K922784 | 000 |
| 05060500091439 | K922784 | 000 |