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510(k) K141468

BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) by Bd Biosciences — Product Code OYE

K141468 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)". The FDA issued a decision of Substantially Equivalent on February 27, 2015. The device falls under product code OYE (Flow Cytometric Reagents And Accessories.), a Class II device regulated under 21 CFR 864.5220. Bd Biosciences has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2015
Date Received
June 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flow Cytometric Reagents And Accessories.
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

Other clearances by Bd Biosciences

  • K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 (July 31, 2009)
  • K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (August 14, 2008)
  • K071143 — BD TRITEST CD3/CD4/CD45, MODEL 340383 (June 6, 2007)
  • K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (June 6, 2007)
  • 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)

Other clearances for product code OYE

  • K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels (November 22, 2023)
  • K201814 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurat (September 28, 2020)
  • K170974 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), (July 3, 2017)
  • K162897 — Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 L (June 23, 2017)
  • K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMU (April 10, 2015)
  • K130373 — NAVIOS FLOW CYTOMETER SYSTEM (September 18, 2013)
  • K121445 — TETRACHROME REAGENTS AND TETRACXP SYSTEM (July 26, 2013)

FDA data resources