Cleared Traditional

VIRGO HSV-2 IGG ELISA

K883281 · Electro-Nucleonics, Inc. · Microbiology
Mar 1989
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K883281 is an FDA 510(k) clearance for the VIRGO HSV-2 IGG ELISA, a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on March 10, 1989, 219 days after receiving the submission on August 3, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K883281 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1988
Decision Date March 10, 1989
Days to Decision 219 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQO — Antisera, Cf, Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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