Home / 510(k) Clearances / K951100

510(k) K951100

ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) by Ortho Diagnostic Systems, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1996
Date Received
March 10, 1995
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 Ortho Diagnostic Systems, Inc.

  • K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (July 14, 1997)
  • K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (March 6, 1997)
  • K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (January 22, 1997)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 10, 1996)
  • K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTE (May 9, 1996)
  • K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (April 30, 1996)
  • K955638 — SYNTHAFAX APTT REAGENT (April 23, 1996)

Other clearances for product code GKZ

  • K243348 — Athelas Home (February 6, 2026)
  • K251249 — Tru Hematology Test (January 16, 2026)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250943 — Sysmex XR-Series (XR-10) 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)