ANTI-TPO

Immunochemical, Thyroglobulin Autoantibody

BIOMERICA, INC.

The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Anti-tpo.

Pre-market Notification Details

Device IDK954256
510k NumberK954256
Device Name:ANTI-TPO
ClassificationImmunochemical, Thyroglobulin Autoantibody
Applicant BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach,  CA  92663
ContactPerry Rucker
CorrespondentPerry Rucker
BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach,  CA  92663
Product CodeJNL  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-05
Decision Date1995-11-27

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