Cleared Traditional

IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES

K962360 · Scimedx Corp. · Immunology
Sep 1996
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K962360 is an FDA 510(k) clearance for the IFA KIT FOR THE DETECTION OF C-ANCA 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 September 30, 1996, 103 days after receiving the submission on June 19, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K962360 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1996
Decision Date September 30, 1996
Days to Decision 103 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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