The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Glucose Reagent Kit.
| Device ID | K903063 |
| 510k Number | K903063 |
| Device Name: | SYNERMED GLUCOSE REAGENT KIT |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SYNERMED, INC. 445 BOUL. INDUSTRIEL ST-EUSTANCHE Quebec, CA J745r3 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED, INC. 445 BOUL. INDUSTRIEL ST-EUSTANCHE Quebec, CA J745r3 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-09 |
| Decision Date | 1990-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091897 | K903063 | 000 |
| 05060500090975 | K903063 | 000 |
| 05060500090968 | K903063 | 000 |
| 05060500090951 | K903063 | 000 |
| 05060500090944 | K903063 | 000 |
| 05060500090937 | K903063 | 000 |
| 05060500090920 | K903063 | 000 |