SERODIA ATG

Thyroglobulin, Antigen, Antiserum, Control

FUJIREBIO AMERICA, INC.

The following data is part of a premarket notification filed by Fujirebio America, Inc. with the FDA for Serodia Atg.

Pre-market Notification Details

Device IDK953066
510k NumberK953066
Device Name:SERODIA ATG
ClassificationThyroglobulin, Antigen, Antiserum, Control
Applicant FUJIREBIO AMERICA, INC. 1129 BLOOMFIELD AVE. West Caldwell,  NJ  07006
ContactRobert Scjoff
CorrespondentRobert Scjoff
FUJIREBIO AMERICA, INC. 1129 BLOOMFIELD AVE. West Caldwell,  NJ  07006
Product CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-30
Decision Date1995-08-14

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