HDL EZ-TZ3 CHOLESTEROL REAGENT KIT

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

PREVENTIVE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Hdl Ez-tz3 Cholesterol Reagent Kit.

Pre-market Notification Details

Device IDK840677
510k NumberK840677
Device Name:HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-15
Decision Date1984-04-13

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