Cleared Traditional

K940473 - ENTEROVIRUS 71 MONOCLONAL ANTIBODY
(FDA 510(k) Clearance)

K940473 · Chemicon Intl., Inc. · Microbiology

Sep 1995

Decision

587d

Days

Class 1

Risk

K940473 is an FDA 510(k) clearance for the ENTEROVIRUS 71 MONOCLONAL ANTIBODY. This device is classified as 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, 587 days after receiving the submission on February 2, 1994.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number	K940473 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1994
Decision Date	September 12, 1995
Days to Decision	587 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF