VIROGEN HERPES SLIDE TEST— 510(k) K852928

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K852928 for VIROGEN HERPES SLIDE TEST, Substantially Equivalent on 1985-10-17. 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: 1985-07-09
Decision date: 1985-10-17
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
K871426 — VIROGEN HSV ANTIBODY TEST1987-10-15

More clearances from Armkel, LLC

K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST2004-10-19
K030258 — FIRST RESPONSE PREGNANCY TEST2003-02-25
K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS2002-12-16
K013433 — TROJAN PASSION BERRY GEL2002-03-05
K013614 — TROJAN CRYSTAL CLEAR LIQUID2002-02-01

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