FDA 510(k) Application Details - K954778

Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

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510(K) Number K954778
Device Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant CHOLESTECH CORP.
3347 INVESTMENT BLVD.
HAYWARD, CA US
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Contact GARY E HEWETT
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Regulation Number 862.1475

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Classification Product Code LBS
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Date Received 09/19/1995
Decision Date 11/24/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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