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510(k) K000611

STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER by Bd Biosciences — Product Code GKZ

K000611 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER". The FDA issued a decision of Substantially Equivalent on May 18, 2000. The device falls under product code GKZ (Counter, Differential Cell), 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
May 18, 2000
Date Received
February 23, 2000
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

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)
  • 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)
  • K000897 — CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE (May 5, 2000)

Other clearances for product code GKZ

  • K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers (May 27, 2026)
  • 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)

FDA data resources