Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
164 devices
Cleared
Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
Chemistry
370d
Cleared
May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
Hematology
196d
Cleared
May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
Chemistry
70d
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
Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
Chemistry
126d
Cleared
Nov 09, 1993
IRON/UIBC REAGENT
Chemistry
168d
Cleared
Oct 18, 1993
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
Chemistry
123d
Cleared
Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
Toxicology
48d
Cleared
May 11, 1993
THROMBOPLATIN-M WITH CALCIUM
Hematology
116d
Cleared
Mar 04, 1992
FIBRINOGEN CONTROL
Hematology
91d
Cleared
Feb 18, 1992
MICROPROTEIN-PR
Chemistry
81d
Cleared
Jan 27, 1992
DIGITOXIN FPIA REAGENT SET
Toxicology
56d
Cleared
Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
Hematology
50d
Cleared
Jan 15, 1992
DIGITOXIN FPIA CALIBRATOR SET
Toxicology
44d
Cleared
Dec 27, 1991
SIGMA PROCEDURE NO. 333-UV
Toxicology
65d
Cleared
Oct 09, 1991
FIBRINOGEN DETERMINATION KIT
Hematology
91d
Cleared
Sep 11, 1991
AMYLASE REAGENT (PROCEDURE 577)
Chemistry
15d
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 03, 1990
SIGMA PROCEDURE NO. 735
Chemistry
98d
Cleared
Oct 04, 1989
CALCIUM (ARSENAZO III) REAGENT
Chemistry
107d
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