HDL EZ-TAB

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 Ez-tab.

Pre-market Notification Details

Device IDK833160
510k NumberK833160
Device Name:HDL EZ-TAB
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 Received1983-09-16
Decision Date1984-02-09

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