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510(k) K790122

RUBANON by Organon, Inc. — Product Code GOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1979
Date Received
January 23, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Hai (Including Hai Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

Other clearances by Organon, Inc.

  • K950861 — RECONSTITUTION ACCESSOREIS (May 26, 1995)
  • K853388 — MONOSTICON UNI-DOT (August 22, 1985)
  • K842314 — DUOCLON COLOR-CEPT (August 24, 1984)
  • K841525 — OREIA II B-HCG PREGNANCY TEST KIT (June 5, 1984)
  • K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT (May 22, 1984)
  • K840650 — B-NEOCEPT 30 (April 4, 1984)
  • K832801 — OREIA II B-HCG, ENZYME INNUNOASSAY (December 8, 1983)
  • K831339 — NEO-PREGNOSTICON DUOCLON TUBE TEST (June 8, 1983)
  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)
  • K823682 — BETA FFIRM TEST (January 7, 1983)

Other clearances for product code GOK

  • K832228 — RUBASCAN LATEX CARD TEST (September 29, 1983)
  • K810835 — RUBAZYME - M (May 5, 1981)
  • K792635 — ANTIBODY TO RUBELLA VIRUS (March 19, 1980)
  • K792133 — RUBELISA TEST KIT (January 11, 1980)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K780063 — RUBENOSTICON (January 20, 1978)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)
  • K771956 — HUMAN O BUFFER (October 28, 1977)