TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL

Enzymatic Esterase--oxidase, Cholesterol

CHOLESTECH CORP.

The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Total Cholesterolm Hdl Cholesterol And Triglycerides Panel.

Pre-market Notification Details

Device IDK946065
510k NumberK946065
Device Name:TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward,  CA  94545
ContactGary Hewett
CorrespondentGary Hewett
CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward,  CA  94545
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-15
Decision Date1995-02-22

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