Cleared Traditional

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI

K883670 · Electro-Nucleonics, Inc. · Microbiology
Apr 1989
Decision
253d
Days
Class 1
Risk

About This 510(k) Submission

K883670 is an FDA 510(k) clearance for the SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI, a Antiserum, Cf, Epstein-barr Virus (Class I — General Controls, product code GNP), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on April 28, 1989, 253 days after receiving the submission on August 18, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K883670 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1988
Decision Date April 28, 1989
Days to Decision 253 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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