VIROGEN HSV ANTIBODY TEST— 510(k) K871426

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K871426 for VIROGEN HSV ANTIBODY TEST, Substantially Equivalent on 1987-10-15. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code GQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1987-04-09
Decision date: 1987-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQO

K883281 — VIRGO HSV-2 IGG ELISA1989-03-10
K883282 — VIRGO HSV-1 IGG ELISA1989-03-10
K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM1988-06-07
K875366 — THE DDI SERODOT HERPES IGG TEST KIT1988-05-23
K861120 — THE GOLDEN QUAD TEST (HSV)1987-02-02

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Data sourced from openFDA. This site is unofficial and independent of the FDA.