LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

Lipoprotein, Low-density, Antigen, Antiserum, Control

DIASORIN/AMERICAN STANDARD COMPANIES

The following data is part of a premarket notification filed by Diasorin/american Standard Companies with the FDA for Lipoprotein (a) Spq Iii Antibody Reagent Set.

Pre-market Notification Details

Device IDK994110
510k NumberK994110
Device Name:LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
ClassificationLipoprotein, Low-density, Antigen, Antiserum, Control
Applicant DIASORIN/AMERICAN STANDARD COMPANIES 9175 GUILFORD RD., SUITE 100 QUARRY PARK PLACE Columbia,  MD  21046
ContactJudith J Smith
CorrespondentJudith J Smith
DIASORIN/AMERICAN STANDARD COMPANIES 9175 GUILFORD RD., SUITE 100 QUARRY PARK PLACE Columbia,  MD  21046
Product CodeDFC  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-06
Decision Date1999-12-21
Summary:summary

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