Cleared Traditional

COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY

K936252 · Light Diagnostics · Microbiology
Sep 1995
Decision
617d
Days
Class 1
Risk

About This 510(k) Submission

K936252 is an FDA 510(k) clearance for the COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY, a Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 (Class I — General Controls, product code GNM), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on September 8, 1995, 617 days after receiving the submission on December 30, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3145.

Submission Details

510(k) Number K936252 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1993
Decision Date September 08, 1995
Days to Decision 617 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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