STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE

Ldl & Vldl Precipitation, Hdl

NORFOLK SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Statspin Hdl-cholesterol Precipitating Micro Tube.

Pre-market Notification Details

Device IDK890669
510k NumberK890669
Device Name:STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
ClassificationLdl & Vldl Precipitation, Hdl
Applicant NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood,  MA  02062
ContactKelley, Phd
CorrespondentKelley, Phd
NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood,  MA  02062
Product CodeLBR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-09
Decision Date1989-03-08

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