Cleared Traditional

POLIOVIRUS 2 MONOCLONAL ANTIBODY

K940034 · Light Diagnostics · Microbiology
Sep 1995
Decision
616d
Days
Class 1
Risk

About This 510(k) Submission

K940034 is an FDA 510(k) clearance for the POLIOVIRUS 2 MONOCLONAL 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 12, 1995, 616 days after receiving the submission on January 4, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K940034 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1994
Decision Date September 12, 1995
Days to Decision 616 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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