Cleared Traditional

BION EBV-G (VCA) TEST SYSTEM

K891785 · Bion Ent., Ltd. · Microbiology
Aug 1989
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K891785 is an FDA 510(k) clearance for the BION EBV-G (VCA) TEST SYSTEM, a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on August 31, 1989, 160 days after receiving the submission on March 24, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K891785 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1989
Decision Date August 31, 1989
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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