HDL CHOLESTEROL KIT

Ldl & Vldl Precipitation, Hdl

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Hdl Cholesterol Kit.

Pre-market Notification Details

Device IDK881244
510k NumberK881244
Device Name:HDL CHOLESTEROL KIT
ClassificationLdl & Vldl Precipitation, Hdl
Applicant TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
ContactP. J Ruthven
CorrespondentP. J Ruthven
TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
Product CodeLBR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-23
Decision Date1988-06-10

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