The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Cholesterol Reagent Kit.
| Device ID | K903015 |
| 510k Number | K903015 |
| Device Name: | SYNERMED CHOLESTEROL REAGENT KIT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| 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 | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-10 |
| Decision Date | 1990-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091859 | K903015 | 000 |
| 05060500090623 | K903015 | 000 |
| 05060500090616 | K903015 | 000 |
| 05060500090609 | K903015 | 000 |
| 05060500090593 | K903015 | 000 |
| 05060500090586 | K903015 | 000 |
| 05060500090579 | K903015 | 000 |