The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Cholestezyme-v Eiken.
Device ID | K821105 |
510k Number | K821105 |
Device Name: | CHOLESTEZYME-V EIKEN |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-20 |
Decision Date | 1982-05-05 |