ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)

System, Test, Thyroid Autoantibody

AMERICAN LABORATORY PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-tg/anti-tpo Pia (pin Immuno Assay).

Pre-market Notification Details

Device IDK950088
510k NumberK950088
Device Name:ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
ClassificationSystem, Test, Thyroid Autoantibody
Applicant AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham,  NH  03087
ContactRichard E Conley
CorrespondentRichard E Conley
AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham,  NH  03087
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-10
Decision Date1995-04-21

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