MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

Lipoprotein, Low-density, Antigen, Antiserum, Control

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Modification To Lipoprotein (a) Spq Iii Antibody Reagent Set.

Pre-market Notification Details

Device IDK001118
510k NumberK001118
Device Name:MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
ClassificationLipoprotein, Low-density, Antigen, Antiserum, Control
Applicant DIASORIN, INC. 4029 CHARIOT'S FLIGHT WAY Ellicott City,  MD  21042
ContactJudith J Smith
CorrespondentJudith J Smith
DIASORIN, INC. 4029 CHARIOT'S FLIGHT WAY Ellicott City,  MD  21042
Product CodeDFC  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-07
Decision Date2000-04-25

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