ACCUMETER HDL CHOLESTEROL TEST

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

CHEMTRAK, INC.

The following data is part of a premarket notification filed by Chemtrak, Inc. with the FDA for Accumeter Hdl Cholesterol Test.

Pre-market Notification Details

Device IDK943279
510k NumberK943279
Device Name:ACCUMETER HDL CHOLESTEROL TEST
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant CHEMTRAK, INC. 929 E. ARQUES AVE. Sunnyvale,  CA  94086
ContactJill Findlay
CorrespondentJill Findlay
CHEMTRAK, INC. 929 E. ARQUES AVE. Sunnyvale,  CA  94086
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-07
Decision Date1995-05-01

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