ORGENTEC ANTI-JO-1 ELISA

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

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-jo-1 Elisa.

Pre-market Notification Details

Device IDK962053
510k NumberK962053
Device Name:ORGENTEC ANTI-JO-1 ELISA
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
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 CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-28
Decision Date1996-11-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157080102 K962053 000
00404847435818 K962053 000
04048474035810 K962053 000
00840239035813 K962053 000

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