Medical Device Manufacturer · US , Mchenry , IL

Sigma Diagnostics, Inc.

164 submissions · 164 cleared · Since 1984
164
Total
164
Cleared
0
Denied

Sigma Diagnostics, Inc. — FDA 510(k) Submissions

Sigma Diagnostics, Inc. has submitted 164 FDA 510(k) premarket notifications since 1984, of which 164 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Multipurpose For In Vitro Coagulation Studies, Quality Control Slides, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, Plasma, Coagulation Factor Deficient . Use the specialty filter in the sidebar to narrow results.

164 devices
1–25 of 164
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
K021162 · JPA System, Multipurpose For... · Hematology
Aug 2002 141d
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · GGC Control, Plasma, Abnormal · Hematology
Feb 2002 26d
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · DAP Fibrinogen And Fibrin... · Hematology
Dec 2001 63d
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · DAP Fibrinogen And Fibrin... · Hematology
Nov 2001 22d
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · DAP Fibrinogen And Fibrin... · Hematology
Nov 2001 22d
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · LCP Assay, Glycosylated... · Hematology
Oct 2001 88d
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · JIX Calibrator, Multi-analyte... · Chemistry
Mar 2001 25d
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · GGO Reagent, Thromboplastin... · Hematology
Mar 2001 64d
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · DAP Fibrinogen And Fibrin... · Hematology
Mar 2001 148d
ACCUCLOT CONTROL I, MODEL A4089
K003328 · GIZ Plasma, Control, Normal · Hematology
Mar 2001 128d
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · GGC Control, Plasma, Abnormal · Hematology
Mar 2001 128d
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
K001403 · CFR Hexokinase, Glucose · Chemistry
Aug 2000 99d
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · MRR System, Test, Low... · Chemistry
Jul 2000 242d
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · JFJ Catalytic Methods, Amylase · Chemistry
Jun 2000 38d
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527 · GIR Reagent, Russel Viper Venom · Hematology
Apr 2000 50d
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · GIR Reagent, Russel Viper Venom · Hematology
Apr 2000 50d
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · GFO Activated Partial... · Hematology
Dec 1999 117d
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · GFO Activated Partial... · Hematology
Dec 1999 117d
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
K992798 · CDO Acid, Uric, Uricase (u.v.) · Chemistry
Sep 1999 40d
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
K992800 · CDQ Urease And Glutamic... · Chemistry
Sep 1999 40d
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
K992801 · CIT Nadh Oxidation/nad... · Chemistry
Sep 1999 40d
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803 · CHH Enzymatic... · Chemistry
Sep 1999 25d
INFINITY GLUCOSE REAGENT
K984574 · CFR Hexokinase, Glucose · Chemistry
Feb 1999 50d
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · GJA Test, Thrombin Time · Hematology
Oct 1998 114d
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
K982251 · CDO Acid, Uric, Uricase (u.v.) · Chemistry
Aug 1998 53d

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