Cleared Traditional

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES

K954105 · Scimedx Corp. · Immunology
Mar 1996
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K954105 is an FDA 510(k) clearance for the EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on March 19, 1996, 201 days after receiving the submission on August 31, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K954105 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1995
Decision Date March 19, 1996
Days to Decision 201 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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