The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed 600 Nm Uric Acid Reagent Kit.
| Device ID | K923414 |
| 510k Number | K923414 |
| Device Name: | SYNERMED 600 NM URIC ACID REAGENT KIT |
| Classification | Acid, Uric, Uricase (colorimetric) |
| 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 | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091972 | K923414 | 000 |
| 05060500091521 | K923414 | 000 |
| 05060500091514 | K923414 | 000 |
| 05060500091507 | K923414 | 000 |
| 05060500091491 | K923414 | 000 |
| 05060500091484 | K923414 | 000 |
| 05060500091477 | K923414 | 000 |