Home / 510(k) Clearances / K964856

510(k) K964856

CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION by Caltag Laboratories, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
December 4, 1996
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 Caltag Laboratories, Inc.

  • K990641 — CALTAG FETAL HEMOGLOBIN TEST (September 17, 1999)
  • K965232 — CALTAG CAL-LYSE (May 14, 1997)
  • K963954 — CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY (November 25, 1996)
  • K950917 — CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950918 — CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950916 — CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K951073 — CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950919 — CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (December 20, 1995)
  • K944128 — CALTAG CD4 R-PE MONOCLONAL ANTIBODY (June 20, 1995)
  • K944126 — CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES (June 20, 1995)

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)