Home / 510(k) Clearances / K990172

510(k) K990172

TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA by Coulter Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1999
Date Received
January 19, 1999
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 Coulter Corp.

  • K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES (April 20, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS (April 26, 1999)
  • K990352 — COULTER AC T DIFF 2 ANALYZER (April 1, 1999)
  • K984216 — IMMUNO-TROL CONTROL CELLS (March 16, 1999)
  • K982167 — CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH (November 9, 1998)
  • K982166 — CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH (November 5, 1998)
  • K982172 — CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER C (September 24, 1998)
  • K973634 — COULTER AC.T DIFF ANALYZER (October 29, 1997)
  • K971469 — COULTER ACT TRON CELL CONTROL (June 30, 1997)

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