HDL EX-SEP PRECIPITATING REAGENT

Ldl & Vldl Precipitation, Hdl

PREVENTIVE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Hdl Ex-sep Precipitating Reagent.

Pre-market Notification Details

Device IDK833431
510k NumberK833431
Device Name:HDL EX-SEP PRECIPITATING REAGENT
ClassificationLdl & Vldl Precipitation, Hdl
Applicant PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLBR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-05
Decision Date1984-01-13

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