Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
164 devices
Cleared
Sep 07, 1989
TRIGLYCERIDE (GPO) TRINDER REAGENT
Chemistry
91d
Cleared
Mar 28, 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
Chemistry
175d
Cleared
Feb 24, 1989
WRIGHT-GLEMSA STAIN
Pathology
15d
Cleared
Feb 24, 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
Pathology
15d
Cleared
Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
Chemistry
44d
Cleared
Apr 21, 1988
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
Hematology
107d
Cleared
Apr 21, 1988
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
Microbiology
37d
Cleared
Apr 21, 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
Microbiology
37d
Cleared
Apr 21, 1988
FUNGI HISTOLOGY CONTROL SLIDES
Microbiology
37d
Cleared
Apr 12, 1988
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
Microbiology
28d
Cleared
Apr 12, 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
Microbiology
28d
Cleared
Mar 30, 1988
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
Microbiology
15d
Cleared
Mar 30, 1988
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL
Microbiology
15d
Cleared
Mar 15, 1988
CO2 REAGENT
Chemistry
54d
Cleared
Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
Chemistry
50d
Cleared
Feb 09, 1988
RETICULOCYTE STAIN
Pathology
42d
Cleared
Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
Immunology
26d
Cleared
Oct 20, 1987
BILE ACIDS CONTROLS
Chemistry
62d
Cleared
Oct 02, 1987
CREATININE REAGENT
Chemistry
42d
Cleared
Aug 26, 1987
BILE ACIDS REAGENT
Chemistry
71d
Cleared
Aug 21, 1987
BILE ACIDS CALIBRATOR
Chemistry
59d
Cleared
Aug 13, 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
Chemistry
66d
Cleared
Jul 16, 1987
CHOLESTEROL REAGENT
Chemistry
30d
Cleared
Jul 07, 1987
DIGOXIN FPIA CONTROLS
Toxicology
20d
Cleared
Jul 01, 1987
PHENYTOIN FPIA CONTROLS
Chemistry
70d
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