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N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

Genzyme Corp. · Class I · Cleared Jun 16, 1997

K-numberK971190
Device nameN-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
ApplicantGenzyme Corp.
Product codeLBS
Device classClass I
Decision dateJun 16, 1997
DecisionSubstantially Equivalent
Regulation862.1475
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