ORGENTEC ANTI-SM 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-sm Elisa.

Pre-market Notification Details

Device IDK962062
510k NumberK962062
Device Name:ORGENTEC ANTI-SM 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 Date1996-11-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157080072 K962062 000
00404847435771 K962062 000
04048474035773 K962062 000
00840239035776 K962062 000

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