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510(k) K944127

CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY by Caltag Laboratories, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
August 23, 1994
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)
  • K964856 — CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (January 17, 1997)
  • K963954 — CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY (November 25, 1996)
  • K950918 — CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950916 — CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950917 — CD3 FITC/CD8 R-PE/CD45 TRI-COLOR 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)

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