ORGENTEC ANTI-CARDIOLIPIN SCREEN 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 Screen Elisa Assay.

Pre-market Notification Details

Device IDK962926
510k NumberK962926
Device Name:ORGENTEC ANTI-CARDIOLIPIN SCREEN 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 Received1996-07-29
Decision Date1996-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157080140 K962926 000
00404847435894 K962926 000
04048474035896 K962926 000
00840239035899 K962926 000

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