ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE

Enzymatic Esterase--oxidase, Cholesterol

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ultrachem Enzymatic Cholesterol Oxidase.

Pre-market Notification Details

Device IDK823354
510k NumberK823354
Device Name:ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant EMD CHEMICALS 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 Received1982-11-05
Decision Date1982-12-22

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