The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Triglycerides Reagent Kit.
| Device ID | K903016 |
| 510k Number | K903016 |
| Device Name: | SYNERMED TRIGLYCERIDES REAGENT KIT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | SYNERMED, INC. 445 BOUL. INDUSTRIEL ST-EUSTANCHE Quebec, CA J745r3 |
| Contact | Marcia Arentz |
| Correspondent | Marcia Arentz SYNERMED, INC. 445 BOUL. INDUSTRIEL ST-EUSTANCHE Quebec, CA J745r3 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-10 |
| Decision Date | 1990-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091958 | K903016 | 000 |
| 05060500091422 | K903016 | 000 |
| 05060500091415 | K903016 | 000 |
| 05060500091408 | K903016 | 000 |
| 05060500091392 | K903016 | 000 |
| 05060500091385 | K903016 | 000 |