Cleared Traditional

VIRGO(R) VZV-IGG ELISA

K883427 · Electro-Nucleonics, Inc. · Microbiology
Mar 1989
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K883427 is an FDA 510(k) clearance for the VIRGO(R) VZV-IGG ELISA, a Antiserum, Cf, Varicella-zoster (Class II — Special Controls, product code GQX), submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on March 10, 1989, 207 days after receiving the submission on August 15, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K883427 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1988
Decision Date March 10, 1989
Days to Decision 207 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQX — Antiserum, Cf, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

Similar Devices — GQX Antiserum, Cf, Varicella-zoster

All 10
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · Light Diagnostics · Mar 1996
VZV IGM TEST
K911301 · Gull Laboratories, Inc. · Jul 1991
VZV TEST
K875358 · Gull Laboratories, Inc. · Mar 1988
ENZYGNOST ANTI-VZV IGG TEST
K863317 · Behring Diagnostics, Inc. · Apr 1987
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
K853540 · Idt, A Division of Whittaker M.A. Bioproducts · Feb 1986
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
K852930 · Microbix Biosystems, Inc. · Nov 1985