SERAQUEST ANTI-THYROGLOBULIN

Thyroglobulin, Antigen, Antiserum, Control

QUEST INTL., INC.

The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Seraquest Anti-thyroglobulin.

Pre-market Notification Details

Device IDK023592
510k NumberK023592
Device Name:SERAQUEST ANTI-THYROGLOBULIN
ClassificationThyroglobulin, Antigen, Antiserum, Control
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 CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-25
Decision Date2003-01-06
Summary:summary

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