ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY

System, Test, Anticardiolipin Immunological

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-cardiolipin Iga Elisa Assay.

Pre-market Notification Details

Device IDK962469
510k NumberK962469
Device Name:ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham,  NH  03087
ContactRichard Conley
CorrespondentRichard Conley
AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham,  NH  03087
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-25
Decision Date1996-09-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157080133 K962469 000
00840239035882 K962469 000
04048474035889 K962469 000

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