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510(k) K871426

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

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

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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)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)