MODIFICATION TO SERAQUEST VCA IGM

Antibody Igm, If, Epstein-barr Virus

QUEST INTL., INC.

The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Modification To Seraquest Vca Igm.

Pre-market Notification Details

Device IDK033780
510k NumberK033780
Device Name:MODIFICATION TO SERAQUEST VCA IGM
ClassificationAntibody Igm, If, Epstein-barr Virus
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 CodeLJN  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-04
Decision Date2004-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816057020652 K033780 000
00847865010801 K033780 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.