ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

System, Test, Anticardiolipin Immunological

QUEST INTL., INC.

The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Anti-cardiolipin, Multiple Autoantibodies Immunological Test System.

Pre-market Notification Details

Device IDK003069
510k NumberK003069
Device Name:ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami,  FL  33181
ContactRobert A Cort
CorrespondentRobert A Cort
QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami,  FL  33181
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-02
Decision Date2000-11-27

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