TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE 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 Cholesterol, Hdl Cholesterol And Glucose Panel.

Pre-market Notification Details

Device IDK946066
510k NumberK946066
Device Name:TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE 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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