Cleared Traditional

ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES

K940027 · Chemicon Intl., Inc. · Microbiology
Sep 1995
Decision
617d
Days
Class 1
Risk

About This 510(k) Submission

K940027 is an FDA 510(k) clearance for the ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES, a Antisera, Fluorescent, Poliovirus 1-3 (Class I — General Controls, product code GOE), submitted by Chemicon Intl., Inc. (Temecula, US). The FDA issued a Cleared decision on September 12, 1995, 617 days after receiving the submission on January 3, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K940027 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1994
Decision Date September 12, 1995
Days to Decision 617 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GOE — Antisera, Fluorescent, Poliovirus 1-3
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405

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