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510(k) K810835

RUBAZYME - M by Abbott Laboratories — Product Code GOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
March 25, 1981
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

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Other clearances for product code GOK

  • K832228 — RUBASCAN LATEX CARD TEST (September 29, 1983)
  • K792635 — ANTIBODY TO RUBELLA VIRUS (March 19, 1980)
  • K792133 — RUBELISA TEST KIT (January 11, 1980)
  • K790122 — RUBANON (February 15, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 1978)
  • K780063 — RUBENOSTICON (January 20, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)
  • K771956 — HUMAN O BUFFER (October 28, 1977)