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510(k) K882557

COULTER CLONE B1 MONOCLONAL ANTIBODY by Coulter Immunology — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1988
Date Received
June 21, 1988
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

  • K922745 — CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 (February 5, 1993)
  • K922744 — CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-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)
  • K895917 — CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI (December 29, 1989)
  • K884605 — COULTER CLONE MO2 (August 15, 1989)
  • K893419 — COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) (August 3, 1989)

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