Cleared Traditional

COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY

K936089 · Chemicon Intl., Inc. · Microbiology
Sep 1995
Decision
626d
Days
Class 1
Risk

About This 510(k) Submission

K936089 is an FDA 510(k) clearance for the COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY, a Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 (Class I — General Controls, product code GNM), submitted by Chemicon Intl., Inc. (Temecula, US). The FDA issued a Cleared decision on September 8, 1995, 626 days after receiving the submission on December 21, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3145.

Submission Details

510(k) Number K936089 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1993
Decision Date September 08, 1995
Days to Decision 626 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNM — Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3145

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