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510(k) K062087

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 by Bd Biosciences — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2006
Date Received
July 24, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Bd Biosciences

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  • K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (August 14, 2008)
  • K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (June 6, 2007)
  • K071143 — BD TRITEST CD3/CD4/CD45, MODEL 340383 (June 6, 2007)
  • K060375 — BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 (June 6, 2006)
  • K041074 — BD FACSCANTO WITH BD FACSANTO SOFTWARE (September 17, 2004)
  • K000611 — STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER (May 18, 2000)
  • K000897 — CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE (May 5, 2000)

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