Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED, SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL, SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
164
Total
164
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sigma Diagnostics, Inc. Hematology ✕
42 devices
Cleared
Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...
Hematology
141d
Cleared
Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
Hematology
26d
Cleared
Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
Hematology
63d
Cleared
Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
Hematology
22d
Cleared
Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
Hematology
22d
Cleared
Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
Hematology
88d
Cleared
Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
Hematology
64d
Cleared
Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
Hematology
148d
Cleared
Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
Hematology
128d
Cleared
Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
Hematology
128d
Cleared
Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
Hematology
50d
Cleared
Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Hematology
50d
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