Sigma Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Sigma Diagnostics, Inc. has 164 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 164 cleared submissions from 1984 to 2002. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Sigma Diagnostics, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sigma Diagnostics, Inc.
164 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 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
Chemistry
25d
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
Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...
Chemistry
99d
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