Cleared Traditional

EBV V VCA IGM ELISA KIT MODEL# EBM-200

K020717 · Pan Bio Pty. , Ltd. · Microbiology
Jun 2002
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K020717 is an FDA 510(k) clearance for the EBV V VCA IGM ELISA KIT MODEL# EBM-200, a Antiserum, Cf, Epstein-barr Virus (Class I — General Controls, product code GNP), submitted by Pan Bio Pty. , Ltd. (Windsor, AU). The FDA issued a Cleared decision on June 13, 2002, 100 days after receiving the submission on March 5, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K020717 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2002
Decision Date June 13, 2002
Days to Decision 100 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNP — Antiserum, Cf, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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