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
FDA 510(k) Regulatory Record - Sigma Diagnostics, Inc. Toxicology ✕
16 devices
Cleared
Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
Toxicology
55d
Cleared
Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC...
Toxicology
54d
Cleared
Feb 16, 1996
VANCOMYCIN FPIA REAGENT SET
Toxicology
63d
Cleared
Mar 21, 1995
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
Toxicology
76d
Cleared
Nov 17, 1994
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
Toxicology
119d
Cleared
Oct 27, 1994
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
Toxicology
108d
Cleared
Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
Toxicology
48d
Cleared
Jan 27, 1992
DIGITOXIN FPIA REAGENT SET
Toxicology
56d
Cleared
Jan 15, 1992
DIGITOXIN FPIA CALIBRATOR SET
Toxicology
44d
Cleared
Dec 27, 1991
SIGMA PROCEDURE NO. 333-UV
Toxicology
65d
Cleared
Jul 07, 1987
DIGOXIN FPIA CONTROLS
Toxicology
20d
Cleared
Jun 11, 1987
PHENYTOIN FPIA CALIBRATORS
Toxicology
63d
Cleared
Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
Toxicology
55d
Cleared
Apr 01, 1987
DIGOXIN FPIA REAGENT SET
Toxicology
22d
Cleared
Mar 31, 1987
THEOPHYLLINE FPIA REAGENT SET
Toxicology
21d
Cleared
Mar 31, 1987
PHENYTOIN FPIA REAGENT SET
Toxicology
21d