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510(k) K780010

GOAT ANTI-RUBELLA ANTISERA by Northeast Biomedical Labs., Inc. — Product Code GOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
January 3, 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 Northeast Biomedical Labs., Inc.

  • K780697 — GOAT ANTI-INFLUENZA ANTISERA ATEXAS (May 3, 1978)
  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780006 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780008 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780009 — GUINEA PIG WHOLE SERUM (January 20, 1978)
  • K780007 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

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)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 1978)
  • K780063 — RUBENOSTICON (January 20, 1978)
  • K771956 — HUMAN O BUFFER (October 28, 1977)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)