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510(k) K832228

RUBASCAN LATEX CARD TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
July 11, 1983
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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  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
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  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
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  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code GOK

  • 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)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)
  • K771956 — HUMAN O BUFFER (October 28, 1977)