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510(k) K895917

CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI by Coulter Immunology — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1989
Date Received
October 10, 1989
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 Immunology

  • K922744 — CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 (February 5, 1993)
  • K922745 — CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 (February 5, 1993)
  • K910473 — CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC (October 31, 1991)
  • K911793 — COULTERCLONE (July 9, 1991)
  • K893853 — COULTER CLONE T8 MONOCLONAL ANTIBODY (March 2, 1990)
  • K893852 — COULTER CLONE T4 MONOCLONAL ANTIBODY (March 2, 1990)
  • K894179 — COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY (February 12, 1990)
  • K884605 — COULTER CLONE MO2 (August 15, 1989)
  • K893419 — COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) (August 3, 1989)
  • K884020 — COULTER CLONE B4 MONOCLONAL ANTIBODY (February 3, 1989)

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