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510(k) K792133

RUBELISA TEST KIT by Microbiological Assoc. — Product Code GOK

K792133 is an FDA 510(k) premarket notification submitted by Microbiological Assoc. for the device "RUBELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code GOK (Antisera, Hai (Including Hai Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Microbiological Assoc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
October 22, 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 Microbiological Assoc.

  • K791397 — HERPES EIA TEST KIT (September 24, 1979)
  • K781549 — TOXELISA TEST KIT (December 7, 1978)
  • K780996 — RUBELISA TEST KIT (November 22, 1978)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 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)
  • K790122 — RUBANON (February 15, 1979)
  • 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)
  • K771956 — HUMAN O BUFFER (October 28, 1977)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)

FDA data resources