Cleared Traditional

COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES

K940471 · Chemicon Intl., Inc. · Microbiology
Sep 1995
Decision
583d
Days
Class 1
Risk

About This 510(k) Submission

K940471 is an FDA 510(k) clearance for the COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES, 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, 583 days after receiving the submission on February 2, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3145.

Submission Details

510(k) Number K940471 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1994
Decision Date September 08, 1995
Days to Decision 583 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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