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510(k) K965232

CALTAG CAL-LYSE by Caltag Laboratories, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1997
Date Received
December 31, 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)
  • 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)
  • K944126 — CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES (June 20, 1995)
  • K944128 — CALTAG CD4 R-PE MONOCLONAL ANTIBODY (June 20, 1995)

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