CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS

Enzymatic Esterase--oxidase, Cholesterol

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Cholesterol (total) Analysis Products.

Pre-market Notification Details

Device IDK870928
510k NumberK870928
Device Name:CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
ContactLabrec, Phd
CorrespondentLabrec, Phd
ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia,  MD  21046
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-09
Decision Date1987-04-22

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