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510(k) K842887

HERPES VIRUS AGGLUTINATION TEST by Scientific Research — Product Code GQO

K842887 is an FDA 510(k) premarket notification submitted by Scientific Research for the device "HERPES VIRUS AGGLUTINATION TEST". The FDA issued a decision of Substantially Equivalent on February 26, 1985. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Scientific Research has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1985
Date Received
July 23, 1984
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 Scientific Research

  • K912420 — ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM (September 23, 1991)
  • K843077 — ELISA FOR HERPES SIMPLEX VIRUS (June 21, 1985)
  • K843369 — AGGLUTINATION TEST FOR TOTAL IGE (November 14, 1984)
  • K843710 — ELISA FOR TOTAL IGE (October 22, 1984)

Other clearances for product code GQO

  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 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)
  • K871426 — VIROGEN HSV ANTIBODY TEST (October 15, 1987)
  • 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)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)

FDA data resources