HDL CHOLESTEROL CONTROLS-LEVELS

Calibrator, Multi-analyte Mixture

PREVENTIVE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Hdl Cholesterol Controls-levels.

Pre-market Notification Details

Device IDK840278
510k NumberK840278
Device Name:HDL CHOLESTEROL CONTROLS-LEVELS
ClassificationCalibrator, Multi-analyte Mixture
Applicant PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-23
Decision Date1984-03-23

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