Cleared Traditional

ENTEROVIRUS 70 MONCLONAL ANTIBODY

K940363 · Light Diagnostics · Microbiology
Sep 1995
Decision
590d
Days
Class 1
Risk

About This 510(k) Submission

K940363 is an FDA 510(k) clearance for the ENTEROVIRUS 70 MONCLONAL ANTIBODY, a Antisera, Fluorescent, Poliovirus 1-3 (Class I — General Controls, product code GOE), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on September 8, 1995, 590 days after receiving the submission on January 26, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K940363 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1994
Decision Date September 08, 1995
Days to Decision 590 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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