ORGENTEC ANTI-SCL 70 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-scl 70 Elisa.

Pre-market Notification Details

Device IDK962055
510k NumberK962055
Device Name:ORGENTEC ANTI-SCL 70 ELISA
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. Windham,  NH  03087
ContactRichard Conley
CorrespondentRichard Conley
AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. 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
04260157080096 K962055 000
00404847435801 K962055 000
00840239035806 K962055 000
04048474035803 K962055 000

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