Caltag Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CALTAG FETAL HEMOGLOBIN TEST, CALTAG CAL-LYSE, CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Caltag Laboratories, Inc. Hematology ✕
12 devices
Cleared
Sep 17, 1999
CALTAG FETAL HEMOGLOBIN TEST
Hematology
203d
Cleared
May 14, 1997
CALTAG CAL-LYSE
Hematology
134d
Cleared
Jan 17, 1997
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
Hematology
44d
Cleared
Nov 25, 1996
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
Hematology
54d
Cleared
Dec 21, 1995
CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION
Hematology
295d
Cleared
Dec 21, 1995
CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
Hematology
295d
Cleared
Dec 21, 1995
CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION
Hematology
295d
Cleared
Dec 21, 1995
CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION
Hematology
288d
Cleared
Dec 20, 1995
CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
Hematology
294d
Cleared
Jun 20, 1995
CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES
Hematology
301d
Cleared
Jun 20, 1995
CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY
Hematology
301d
Cleared
Jun 20, 1995
CALTAG CD4 R-PE MONOCLONAL ANTIBODY
Hematology
301d