Cleared Traditional

VIRGO (R) CMV-IGG ELISA

K883102 · Electro-Nucleonics, Inc. · Microbiology
Feb 1989
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K883102 is an FDA 510(k) clearance for the VIRGO (R) CMV-IGG ELISA, a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on February 8, 1989, 201 days after receiving the submission on July 22, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K883102 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1988
Decision Date February 08, 1989
Days to Decision 201 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQI — Antiserum, Cf, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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