Cleared Traditional

VIROGEN HSV ANTIBODY TEST

K871426 · Armkel, LLC · Microbiology
Oct 1987
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K871426 is an FDA 510(k) clearance for the VIROGEN HSV ANTIBODY TEST, a Antisera, Cf, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQO), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on October 15, 1987, 189 days after receiving the submission on April 9, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K871426 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1987
Decision Date October 15, 1987
Days to Decision 189 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
THE GOLDEN QUAD TEST (HSV)
K861120 · Microbiological Research Corp. · Feb 1987
VISIBLE-HERPES TM TEST SYSTEM
K854712 · Isolab, Inc. · May 1986