CHOLESTEZYME-V EIKEN

Enzymatic Esterase--oxidase, Cholesterol

SYN-KIT, INC.

The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Cholestezyme-v Eiken.

Pre-market Notification Details

Device IDK821105
510k NumberK821105
Device Name:CHOLESTEZYME-V EIKEN
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-20
Decision Date1982-05-05

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