ORGENTEC ANTI-TPO ELISA

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-tpo Elisa.

Pre-market Notification Details

Device IDK952129
510k NumberK952129
Device Name:ORGENTEC ANTI-TPO ELISA
ClassificationSystem, Test, Thyroid Autoantibody
Applicant AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. Windham,  NH  03087
ContactRichard E Conley
CorrespondentRichard E Conley
AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. Windham,  NH  03087
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-08
Decision Date1995-06-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157080027 K952129 000
00404847435610 K952129 000
04048474035612 K952129 000
00840239035615 K952129 000

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