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510(k) K081213

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 by Bd Biosciences — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2008
Date Received
April 30, 2008
Clearance Type
Traditional
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

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  • K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (June 6, 2007)
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  • K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MO (September 14, 2006)
  • 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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