Home / 510(k) Clearances / K071143

510(k) K071143

BD TRITEST CD3/CD4/CD45, MODEL 340383 by Bd Biosciences — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2007
Date Received
April 24, 2007
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

  • K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow (February 27, 2015)
  • K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 (July 31, 2009)
  • 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)
  • 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 GKZ

  • K243348 — Athelas Home (February 6, 2026)
  • K251249 — Tru Hematology Test (January 16, 2026)
  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K240402 — Cito CBC System (February 3, 2025)
  • K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer I (July 5, 2024)
  • K232946 — Yumizen H2500 (May 21, 2024)
  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)