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510(k) K781392

CYTOMEGILISH TEST KIT by Microbiological Assoc. — Product Code GOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1978
Date Received
August 10, 1978
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 Microbiological Assoc.

  • K792133 — RUBELISA TEST KIT (January 11, 1980)
  • K791397 — HERPES EIA TEST KIT (September 24, 1979)
  • K781549 — TOXELISA TEST KIT (December 7, 1978)
  • K780996 — RUBELISA TEST KIT (November 22, 1978)
  • K781143 — IMMUNOFLUORESCENCE TEST KIT (August 14, 1978)
  • K770764 — TISSUE CULTURE MEDIA W/HEPES BUFFER (July 21, 1977)
  • K770687 — MEASLESVIRUS FLOURE. CONJUGATED ANTISERU (June 14, 1977)

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)
  • K790122 — RUBANON (February 15, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K780063 — RUBENOSTICON (January 20, 1978)
  • K771956 — HUMAN O BUFFER (October 28, 1977)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)