Sigma Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Sigma Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
SIGMA DIAGNOSTICS, INC.
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED2002-08-30
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL2002-02-06
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A79712001-12-26
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A82212001-11-15
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A80962001-11-15
SIGMA DIAGNOSTICS, INC.
INFINITY HBA KIT, MODELS 537-A, 537-B2001-10-26
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S29362001-03-30
SIGMA DIAGNOSTICS, INC.
THROMBOMAX-HS WITH CALCIUM, MODEL T65402001-03-22
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A2001-03-15
SIGMA DIAGNOSTICS, INC.
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A52172001-03-01
SIGMA DIAGNOSTICS, INC.
ACCUCLOT CONTROL I, MODEL A40892001-03-01
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P2000-08-10
SIGMA DIAGNOSTICS, INC.
EZ LDL CHOLESTEROL TEST SYSTEM2000-07-03
SIGMA DIAGNOSTICS, INC.
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)2000-06-26
SIGMA DIAGNOSTICS, INC.
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A621192000-04-07
SIGMA DIAGNOSTICS, INC.
ACCUCLOT DRVVT SCREEN, CATALOG NO. A60942000-04-07
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A13341999-12-06
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A10941999-12-06
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,51999-09-28
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P1999-09-28
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P1999-09-28
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP1999-09-13
SIGMA DIAGNOSTICS, INC.
INFINITY GLUCOSE REAGENT1999-02-11
SIGMA DIAGNOSTICS, INC.
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A45891998-10-15
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT1998-08-18
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT1998-08-05
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III1998-04-29
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II1998-04-29
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I1998-04-29
SIGMA DIAGNOSTICS, INC.
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)1998-04-21
SIGMA DIAGNOSTICS, INC.
INFINITY AST REAGENT (PROCEDURE NO. 51)1998-03-20
SIGMA DIAGNOSTICS, INC.
ACCUCOLOR HIGH CALIBRATOR (A3089)1997-10-31
SIGMA DIAGNOSTICS, INC.
CS-400 COAGULATION ANALYZER SYSTEM (A1208)1997-10-20
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM1997-10-10
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)1997-10-09
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT1997-09-22
SIGMA DIAGNOSTICS, INC.
DIGOXIN DG-II FPIA REAGENT SET1997-07-31
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS1997-07-30
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III1997-07-25
SIGMA DIAGNOSTICS, INC.
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)1997-07-22
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS GLUCOSE REAGENT1997-01-17
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS WASH CONCENTRATE1996-12-16
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 21996-10-30
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 11996-10-29
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS CO2 ACID REAGENT1996-10-24
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS BUN REAGENT1996-10-24
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER1996-10-11
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS CALICIUM REAGENT1996-10-10
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS CREATININE REAGENT KIT1996-09-30
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT1996-09-27
SIGMA DIAGNOSTICS, INC.
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER1996-09-27
SIGMA DIAGNOSTICS, INC.
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)1996-09-10
SIGMA DIAGNOSTICS, INC.
AMAX CS-190 COAGULATION ANALYZER SYSTEM1996-03-13
SIGMA DIAGNOSTICS, INC.
KC 1A COAGULATION ANALYZER/SET1996-03-12
SIGMA DIAGNOSTICS, INC.
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM1996-03-11
SIGMA DIAGNOSTICS, INC.
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 2451996-02-28
SIGMA DIAGNOSTICS, INC.
VANCOMYCIN FPIA REAGENT SET1996-02-16
SIGMA DIAGNOSTICS, INC.
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS1996-01-24
SIGMA DIAGNOSTICS, INC.
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV1996-01-05
SIGMA DIAGNOSTICS, INC.
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 2471995-08-11
SIGMA DIAGNOSTICS, INC.
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A1995-06-29
SIGMA DIAGNOSTICS, INC.
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)1995-05-08
SIGMA DIAGNOSTICS, INC.
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS1995-03-21
SIGMA DIAGNOSTICS, INC.
IGM RF EIA1995-01-20
SIGMA DIAGNOSTICS, INC.
ANTI DS-DNA1994-12-02
SIGMA DIAGNOSTICS, INC.
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS1994-11-17
SIGMA DIAGNOSTICS, INC.
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR1994-11-10
SIGMA DIAGNOSTICS, INC.
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE1994-11-10
SIGMA DIAGNOSTICS, INC.
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS1994-11-10
SIGMA DIAGNOSTICS, INC.
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS1994-10-27
SIGMA DIAGNOSTICS, INC.
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 4191994-07-20
SIGMA DIAGNOSTICS, INC.
ACT CONTROL SET1994-07-19
SIGMA DIAGNOSTICS, INC.
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS1994-07-13
SIGMA DIAGNOSTICS, INC.
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET1994-07-13
SIGMA DIAGNOSTICS, INC.
APOLIPOPROTIEN A-1 (APO A-1)1994-06-02
SIGMA DIAGNOSTICS, INC.
APOLIPOPROTIEN B (APO B)1994-06-02
SIGMA DIAGNOSTICS, INC.
LIPASE-PS ASSAY PROCEDURE NO. 8051994-05-17
SIGMA DIAGNOSTICS, INC.
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY1994-05-17
SIGMA DIAGNOSTICS, INC.
FACTOR VIII DEFICIENT PLASMA1994-03-15
SIGMA DIAGNOSTICS, INC.
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/78121993-11-16
SIGMA DIAGNOSTICS, INC.
IRON/UIBC REAGENT1993-11-09
SIGMA DIAGNOSTICS, INC.
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18
SIGMA DIAGNOSTICS, INC.
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III1993-06-16
SIGMA DIAGNOSTICS, INC.
THROMBOPLATIN-M WITH CALCIUM1993-05-11
SIGMA DIAGNOSTICS, INC.
FIBRINOGEN CONTROL1992-03-04
SIGMA DIAGNOSTICS, INC.
MICROPROTEIN-PR1992-02-18
SIGMA DIAGNOSTICS, INC.
DIGITOXIN FPIA REAGENT SET1992-01-27
SIGMA DIAGNOSTICS, INC.
ACTIVATED PARTIAL THROMBOPLASTIN TIME1992-01-23
SIGMA DIAGNOSTICS, INC.
DIGITOXIN FPIA CALIBRATOR SET1992-01-15
SIGMA DIAGNOSTICS, INC.
SIGMA PROCEDURE NO. 333-UV1991-12-27
SIGMA DIAGNOSTICS, INC.
FIBRINOGEN DETERMINATION KIT1991-10-09
SIGMA DIAGNOSTICS, INC.
AMYLASE REAGENT (PROCEDURE 577)1991-09-11
SIGMA DIAGNOSTICS, INC.
HEPARIN ADSORBENT1991-07-24
SIGMA DIAGNOSTICS, INC.
HEPARIN CONTROLS, HIGH AND LOW1991-04-29
SIGMA DIAGNOSTICS, INC.
FLOW CYTOMETRY FITC/PE COMPENSATION KIT1991-04-03
SIGMA DIAGNOSTICS, INC.
SIGMA PROCEDURE NO. 7351990-04-03
SIGMA DIAGNOSTICS, INC.
CALCIUM (ARSENAZO III) REAGENT1989-10-04
SIGMA DIAGNOSTICS, INC.
TRIGLYCERIDE (GPO) TRINDER REAGENT1989-09-07
SIGMA DIAGNOSTICS, INC.
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE1989-03-28
SIGMA DIAGNOSTICS, INC.
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET1989-02-24

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