Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
42 devices
Cleared
Mar 12, 1996
KC 1A COAGULATION ANALYZER/SET
Hematology
85d
Cleared
Mar 11, 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
Hematology
84d
Cleared
Jun 29, 1995
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
Hematology
687d
Cleared
Jul 19, 1994
ACT CONTROL SET
Hematology
146d
Cleared
May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
Hematology
196d
Cleared
Mar 15, 1994
FACTOR VIII DEFICIENT PLASMA
Hematology
145d
Cleared
Mar 07, 1994
FACTOR X DEFICIENT PLASMA
Hematology
137d
Cleared
Mar 07, 1994
FACTOR VII DEFICIENT PLASMA
Hematology
137d
Cleared
Mar 07, 1994
FACTOR
Hematology
137d
Cleared
May 11, 1993
THROMBOPLATIN-M WITH CALCIUM
Hematology
116d
Cleared
Mar 04, 1992
FIBRINOGEN CONTROL
Hematology
91d
Cleared
Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
Hematology
50d
Cleared
Oct 09, 1991
FIBRINOGEN DETERMINATION KIT
Hematology
91d
Cleared
Jul 24, 1991
HEPARIN ADSORBENT
Hematology
76d
Cleared
Apr 29, 1991
HEPARIN CONTROLS, HIGH AND LOW
Hematology
67d
Cleared
Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
Hematology
71d
Cleared
Apr 21, 1988
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
Hematology
107d