ORGENTEC ANTI-PR3 (C-ANCA) ELISA

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

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-pr3 (c-anca) Elisa.

Pre-market Notification Details

Device IDK974702
510k NumberK974702
Device Name:ORGENTEC ANTI-PR3 (C-ANCA) ELISA
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
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 CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-08
Decision Date1998-02-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260157080171 K974702 000
00404847435962 K974702 000
04048474035964 K974702 000
00840239035967 K974702 000

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