THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY

Thyroglobulin, Antigen, Antiserum, Control

BIOMERICA, INC.

The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Thyroglobulin Autoantibody Enzyme Immunoassay.

Pre-market Notification Details

Device IDK936010
510k NumberK936010
Device Name:THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
ClassificationThyroglobulin, Antigen, Antiserum, Control
Applicant BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach,  CA  92663
ContactPerry G Rucker
CorrespondentPerry G Rucker
BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach,  CA  92663
Product CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-16
Decision Date1994-07-18

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