Cleared Traditional

THE GOLDEN QUAD TEST (HSV)

K861120 · Microbiological Research Corp. · Microbiology
Feb 1987
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K861120 is an FDA 510(k) clearance for the THE GOLDEN QUAD TEST (HSV), a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on February 2, 1987, 314 days after receiving the submission on March 25, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K861120 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1986
Decision Date February 02, 1987
Days to Decision 314 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

Similar Devices — GQO Antisera, Cf, Herpesvirus Hominis 1,2

All 15
VIRGO HSV-2 IGG ELISA
K883281 · Electro-Nucleonics, Inc. · Mar 1989
VIRGO HSV-1 IGG ELISA
K883282 · Electro-Nucleonics, Inc. · Mar 1989
BION HSV1-G OR HSV2-G TEST SYSTEM
K881261 · Bion Ent., Ltd. · Jun 1988
THE DDI SERODOT HERPES IGG TEST KIT
K875366 · Disease Detection International, Inc. · May 1988
VIROGEN HSV ANTIBODY TEST
K871426 · Armkel, LLC · Oct 1987
VISIBLE-HERPES TM TEST SYSTEM
K854712 · Isolab, Inc. · May 1986