ORGENTEC ABTI-SS-BB(LA) 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 Abti-ss-bb(la) Elisa.

Pre-market Notification Details

Device IDK962052
510k NumberK962052
Device Name:ORGENTEC ABTI-SS-BB(LA) 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
04260157080065 K962052 000
00404847435764 K962052 000
04048474035766 K962052 000
00084023903579 K962052 000

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