CHOLAR PRODU&T #17010

Enzymatic Esterase--oxidase, Cholesterol

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Cholar Produ&t #17010.

Pre-market Notification Details

Device IDK771731
510k NumberK771731
Device Name:CHOLAR PRODU&T #17010
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-09-14
Decision Date1977-10-25

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