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510(k) K871426

VIROGEN HSV ANTIBODY TEST by Armkel, LLC — Product Code GQO

K871426 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "VIROGEN HSV ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on October 15, 1987. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Armkel, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
April 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Armkel, LLC

  • K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (October 19, 2004)
  • K030258 — FIRST RESPONSE PREGNANCY TEST (February 25, 2003)
  • K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS (December 16, 2002)
  • K013433 — TROJAN PASSION BERRY GEL (March 5, 2002)
  • K013614 — TROJAN CRYSTAL CLEAR LIQUID (February 1, 2002)
  • K001212 — TROJAN EXTRA LARGE LATEX CONDOM (May 9, 2000)
  • K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (April 6, 2000)
  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
  • K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST (October 27, 1997)
  • K973352 — BRAND NAME *1-STEP PREGNANCY (October 27, 1997)

Other clearances for product code GQO

  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)
  • K875366 — THE DDI SERODOT HERPES IGG TEST KIT (May 23, 1988)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K854712 — VISIBLE-HERPES TM TEST SYSTEM (May 20, 1986)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)

FDA data resources