The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Total Protein Reagent Kit.
| Device ID | K903511 |
| 510k Number | K903511 |
| Device Name: | SYNERMED TOTAL PROTEIN REAGENT KIT |
| Classification | Biuret (colorimetric), Total Protein |
| 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 | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1990-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091941 | K903511 | 000 |
| 05060500091293 | K903511 | 000 |
| 05060500091309 | K903511 | 000 |
| 05060500091316 | K903511 | 000 |
| 05060500091323 | K903511 | 000 |
| 05060500091330 | K903511 | 000 |
| 05060500091347 | K903511 | 000 |
| 05060500091354 | K903511 | 000 |
| 05060500091361 | K903511 | 000 |
| 05060500091286 | K903511 | 000 |