Cleared Traditional

K974702 - ORGENTEC ANTI-PR3 (C-ANCA) ELISA
(FDA 510(k) Clearance)

K974702 · American Laboratory Products Co., Ltd. · Immunology
Feb 1998
Decision
71d
Days
Class 2
Risk

K974702 is an FDA 510(k) clearance for the ORGENTEC ANTI-PR3 (C-ANCA) ELISA, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on February 17, 1998, 71 days after receiving the submission on December 8, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K974702 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1997
Decision Date February 17, 1998
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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