Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
86 devices
Cleared
Sep 27, 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
Chemistry
23d
Cleared
Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
Chemistry
131d
Cleared
Jan 24, 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
Chemistry
236d
Cleared
Jan 05, 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
Chemistry
77d
Cleared
Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
Chemistry
127d
Cleared
May 08, 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
Chemistry
157d
Cleared
Nov 10, 1994
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
Chemistry
94d
Cleared
Nov 10, 1994
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
Chemistry
83d
Cleared
Nov 10, 1994
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
Chemistry
64d
Cleared
Jul 20, 1994
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
Chemistry
218d
Cleared
Jul 13, 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
Chemistry
155d
Cleared
Jul 13, 1994
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
Chemistry
70d
Cleared
Jun 02, 1994
APOLIPOPROTIEN B (APO B)
Chemistry
370d
Cleared
Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
Chemistry
370d
Cleared
May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
Chemistry
70d
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
Feb 18, 1992
MICROPROTEIN-PR
Chemistry
81d
Cleared
Sep 11, 1991
AMYLASE REAGENT (PROCEDURE 577)
Chemistry
15d
Cleared
Apr 03, 1990
SIGMA PROCEDURE NO. 735
Chemistry
98d
Cleared
Oct 04, 1989
CALCIUM (ARSENAZO III) REAGENT
Chemistry
107d
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 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
Chemistry
44d
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