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Sigma Diagnostics, Inc.

164 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED (K021162)Sigma Diagnostics, Inc.2002-08-30
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (K020109)Sigma Diagnostics, Inc.2002-02-06
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (K013549)Sigma Diagnostics, Inc.2001-12-26
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (K013545)Sigma Diagnostics, Inc.2001-11-15
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (K013544)Sigma Diagnostics, Inc.2001-11-15
INFINITY HBA KIT, MODELS 537-A, 537-B (K012410)Sigma Diagnostics, Inc.2001-10-26
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (K010652)Sigma Diagnostics, Inc.2001-03-30
THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (K010158)Sigma Diagnostics, Inc.2001-03-22
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (K003267)Sigma Diagnostics, Inc.2001-03-15
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (K003329)Sigma Diagnostics, Inc.2001-03-01
ACCUCLOT CONTROL I, MODEL A4089 (K003328)Sigma Diagnostics, Inc.2001-03-01
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P (K001403)Sigma Diagnostics, Inc.2000-08-10
EZ LDL CHOLESTEROL TEST SYSTEM (K993741)Sigma Diagnostics, Inc.2000-07-03
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) (K001569)Sigma Diagnostics, Inc.2000-06-26
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (K000528)Sigma Diagnostics, Inc.2000-04-07
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (K000527)Sigma Diagnostics, Inc.2000-04-07
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (K992712)Sigma Diagnostics, Inc.1999-12-06
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (K992711)Sigma Diagnostics, Inc.1999-12-06
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 (K992801)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P (K992800)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP (K992803)Sigma Diagnostics, Inc.1999-09-13
INFINITY GLUCOSE REAGENT (K984574)Sigma Diagnostics, Inc.1999-02-11
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (K982209)Sigma Diagnostics, Inc.1998-10-15
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251)Sigma Diagnostics, Inc.1998-08-18
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT (K982236)Sigma Diagnostics, Inc.1998-08-05
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I (K981248)Sigma Diagnostics, Inc.1998-04-29
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III (K981255)Sigma Diagnostics, Inc.1998-04-29
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II (K981254)Sigma Diagnostics, Inc.1998-04-29
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) (K980667)Sigma Diagnostics, Inc.1998-04-21
INFINITY AST REAGENT (PROCEDURE NO. 51) (K980666)Sigma Diagnostics, Inc.1998-03-20
ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274)Sigma Diagnostics, Inc.1997-10-31
CS-400 COAGULATION ANALYZER SYSTEM (A1208) (K972260)Sigma Diagnostics, Inc.1997-10-20
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM (K972796)Sigma Diagnostics, Inc.1997-10-10
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (K971858)Sigma Diagnostics, Inc.1997-10-09
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT (K972743)Sigma Diagnostics, Inc.1997-09-22
DIGOXIN DG-II FPIA REAGENT SET (K972794)Sigma Diagnostics, Inc.1997-07-31
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS (K972132)Sigma Diagnostics, Inc.1997-07-30
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III (K972144)Sigma Diagnostics, Inc.1997-07-25
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) (K972041)Sigma Diagnostics, Inc.1997-07-22
SIGMA DIAGNOSTICS GLUCOSE REAGENT (K963535)Sigma Diagnostics, Inc.1997-01-17
SIGMA DIAGNOSTICS WASH CONCENTRATE (K963539)Sigma Diagnostics, Inc.1996-12-16
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 (K963543)Sigma Diagnostics, Inc.1996-10-30
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 (K963533)Sigma Diagnostics, Inc.1996-10-29
SIGMA DIAGNOSTICS CO2 ACID REAGENT (K963541)Sigma Diagnostics, Inc.1996-10-24
SIGMA DIAGNOSTICS BUN REAGENT (K963537)Sigma Diagnostics, Inc.1996-10-24
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (K963538)Sigma Diagnostics, Inc.1996-10-11
SIGMA DIAGNOSTICS CALICIUM REAGENT (K963536)Sigma Diagnostics, Inc.1996-10-10
SIGMA DIAGNOSTICS CREATININE REAGENT KIT (K963534)Sigma Diagnostics, Inc.1996-09-30
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (K963540)Sigma Diagnostics, Inc.1996-09-27
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT (K963542)Sigma Diagnostics, Inc.1996-09-27
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) (K960875)Sigma Diagnostics, Inc.1996-09-10
AMAX CS-190 COAGULATION ANALYZER SYSTEM (K955720)Sigma Diagnostics, Inc.1996-03-13
KC 1A COAGULATION ANALYZER/SET (K955724)Sigma Diagnostics, Inc.1996-03-12
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM (K955735)Sigma Diagnostics, Inc.1996-03-11
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 (K954840)Sigma Diagnostics, Inc.1996-02-28
VANCOMYCIN FPIA REAGENT SET (K955716)Sigma Diagnostics, Inc.1996-02-16
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS (K952557)Sigma Diagnostics, Inc.1996-01-24
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV (K954839)Sigma Diagnostics, Inc.1996-01-05
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 (K951584)Sigma Diagnostics, Inc.1995-08-11
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (K933934)Sigma Diagnostics, Inc.1995-06-29
GLUCOSE (HK) REAGENT (PROCEDURE NO.16) (K945908)Sigma Diagnostics, Inc.1995-05-08
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (K950028)Sigma Diagnostics, Inc.1995-03-21
IGM RF EIA (K942908)Sigma Diagnostics, Inc.1995-01-20
ANTI DS-DNA (K943291)Sigma Diagnostics, Inc.1994-12-02
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (K943550)Sigma Diagnostics, Inc.1994-11-17
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (K944063)Sigma Diagnostics, Inc.1994-11-10
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS (K943866)Sigma Diagnostics, Inc.1994-11-10
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (K944371)Sigma Diagnostics, Inc.1994-11-10
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313)Sigma Diagnostics, Inc.1994-10-27
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (K935984)Sigma Diagnostics, Inc.1994-07-20
ACT CONTROL SET (K940840)Sigma Diagnostics, Inc.1994-07-19
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET (K940569)Sigma Diagnostics, Inc.1994-07-13
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (K942192)Sigma Diagnostics, Inc.1994-07-13
APOLIPOPROTIEN B (APO B) (K932603)Sigma Diagnostics, Inc.1994-06-02
APOLIPOPROTIEN A-1 (APO A-1) (K932606)Sigma Diagnostics, Inc.1994-06-02
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY (K935308)Sigma Diagnostics, Inc.1994-05-17
LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085)Sigma Diagnostics, Inc.1994-05-17
FACTOR VIII DEFICIENT PLASMA (K935057)Sigma Diagnostics, Inc.1994-03-15
FACTOR VII DEFICIENT PLASMA (K935056)Sigma Diagnostics, Inc.1994-03-07
FACTOR (K935058)Sigma Diagnostics, Inc.1994-03-07
FACTOR X DEFICIENT PLASMA (K935054)Sigma Diagnostics, Inc.1994-03-07
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 (K933425)Sigma Diagnostics, Inc.1993-11-16
IRON/UIBC REAGENT (K932517)Sigma Diagnostics, Inc.1993-11-09
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (K932980)Sigma Diagnostics, Inc.1993-10-18
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III (K932067)Sigma Diagnostics, Inc.1993-06-16
THROMBOPLATIN-M WITH CALCIUM (K930212)Sigma Diagnostics, Inc.1993-05-11
FIBRINOGEN CONTROL (K915462)Sigma Diagnostics, Inc.1992-03-04
MICROPROTEIN-PR (K915380)Sigma Diagnostics, Inc.1992-02-18
DIGITOXIN FPIA REAGENT SET (K915465)Sigma Diagnostics, Inc.1992-01-27
ACTIVATED PARTIAL THROMBOPLASTIN TIME (K915463)Sigma Diagnostics, Inc.1992-01-23
DIGITOXIN FPIA CALIBRATOR SET (K915464)Sigma Diagnostics, Inc.1992-01-15
SIGMA PROCEDURE NO. 333-UV (K914777)Sigma Diagnostics, Inc.1991-12-27
FIBRINOGEN DETERMINATION KIT (K913061)Sigma Diagnostics, Inc.1991-10-09
AMYLASE REAGENT (PROCEDURE 577) (K913858)Sigma Diagnostics, Inc.1991-09-11
HEPARIN ADSORBENT (K912061)Sigma Diagnostics, Inc.1991-07-24
HEPARIN CONTROLS, HIGH AND LOW (K910741)Sigma Diagnostics, Inc.1991-04-29
FLOW CYTOMETRY FITC/PE COMPENSATION KIT (K910255)Sigma Diagnostics, Inc.1991-04-03
SIGMA PROCEDURE NO. 735 (K897147)Sigma Diagnostics, Inc.1990-04-03
CALCIUM (ARSENAZO III) REAGENT (K894204)Sigma Diagnostics, Inc.1989-10-04
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