Cleared Traditional

ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS

K936073 · Chemicon Intl., Inc. · Microbiology
Sep 1995
Decision
627d
Days
Class 1
Risk

About This 510(k) Submission

K936073 is an FDA 510(k) clearance for the ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS, 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, 627 days after receiving the submission on December 20, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3145.

Submission Details

510(k) Number K936073 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1993
Decision Date September 08, 1995
Days to Decision 627 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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