The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Urea Nitrogen Reagent Kit.
| Device ID | K911248 |
| 510k Number | K911248 |
| Device Name: | SYNERMED UREA NITROGEN REAGENT KIT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-21 |
| Decision Date | 1991-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091804 | K911248 | 000 |
| 05060500091798 | K911248 | 000 |
| 05060500091781 | K911248 | 000 |
| 05060500091774 | K911248 | 000 |
| 05060500091767 | K911248 | 000 |
| 05060500091750 | K911248 | 000 |
| 05060500091743 | K911248 | 000 |
| 05060500091736 | K911248 | 000 |