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Caltag Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K990641CALTAG FETAL HEMOGLOBIN TESTSeptember 17, 1999
K965232CALTAG CAL-LYSEMay 14, 1997
K964856CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONJanuary 17, 1997
K963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODYNovember 25, 1996
K950917CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONDecember 21, 1995
K950916CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATIONDecember 21, 1995
K950918CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATIONDecember 21, 1995
K951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATIONDecember 21, 1995
K950919CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONDecember 20, 1995
K944128CALTAG CD4 R-PE MONOCLONAL ANTIBODYJune 20, 1995
K944126CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIESJune 20, 1995
K944127CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODYJune 20, 1995