FDA 510(k) Applications Submitted by SIGMA DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K982251 06/26/1998 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT SIGMA DIAGNOSTICS, INC.
K952557 06/02/1995 TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS SIGMA DIAGNOSTICS, INC.
K020109 01/11/2002 SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL SIGMA DIAGNOSTICS, INC.
K000527 02/17/2000 ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 SIGMA DIAGNOSTICS, INC.
K000528 02/17/2000 ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 SIGMA DIAGNOSTICS, INC.
K980667 02/20/1998 INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) SIGMA DIAGNOSTICS, INC.
K980666 02/20/1998 INFINITY AST REAGENT (PROCEDURE NO. 51) SIGMA DIAGNOSTICS, INC.
K001403 05/03/2000 SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P SIGMA DIAGNOSTICS, INC.
K001569 05/19/2000 INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) SIGMA DIAGNOSTICS, INC.
K971858 05/20/1997 SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) SIGMA DIAGNOSTICS, INC.
K972041 06/02/1997 EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) SIGMA DIAGNOSTICS, INC.
K972794 06/06/1997 DIGOXIN DG-II FPIA REAGENT SET SIGMA DIAGNOSTICS, INC.
K972144 06/06/1997 SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III SIGMA DIAGNOSTICS, INC.
K972132 06/06/1997 SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS SIGMA DIAGNOSTICS, INC.
K972260 06/17/1997 CS-400 COAGULATION ANALYZER SYSTEM (A1208) SIGMA DIAGNOSTICS, INC.
K982236 06/25/1998 SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT SIGMA DIAGNOSTICS, INC.
K972743 07/23/1997 SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT SIGMA DIAGNOSTICS, INC.
K972796 07/28/1997 SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM SIGMA DIAGNOSTICS, INC.
K992712 08/11/1999 SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 SIGMA DIAGNOSTICS, INC.
K992711 08/11/1999 SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 SIGMA DIAGNOSTICS, INC.
K992803 08/19/1999 SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP SIGMA DIAGNOSTICS, INC.
K992798 08/19/1999 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P SIGMA DIAGNOSTICS, INC.
K992800 08/19/1999 SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P SIGMA DIAGNOSTICS, INC.
K992801 08/19/1999 SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 SIGMA DIAGNOSTICS, INC.
K973274 09/02/1997 ACCUCOLOR HIGH CALIBRATOR (A3089) SIGMA DIAGNOSTICS, INC.
K963536 09/03/1996 SIGMA DIAGNOSTICS CALICIUM REAGENT SIGMA DIAGNOSTICS, INC.
K963534 09/04/1996 SIGMA DIAGNOSTICS CREATININE REAGENT KIT SIGMA DIAGNOSTICS, INC.
K963535 09/04/1996 SIGMA DIAGNOSTICS GLUCOSE REAGENT SIGMA DIAGNOSTICS, INC.
K963537 09/04/1996 SIGMA DIAGNOSTICS BUN REAGENT SIGMA DIAGNOSTICS, INC.
K963538 09/04/1996 SIGMA DIAGNOSTICS CO2ALKALINE BUFFER SIGMA DIAGNOSTICS, INC.
K963543 09/04/1996 SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 SIGMA DIAGNOSTICS, INC.
K963539 09/04/1996 SIGMA DIAGNOSTICS WASH CONCENTRATE SIGMA DIAGNOSTICS, INC.
K963540 09/04/1996 SIGMA DIAGNOSTICS ELECTROLYTE BUFFER SIGMA DIAGNOSTICS, INC.
K963542 09/04/1996 SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT SIGMA DIAGNOSTICS, INC.
K963533 09/04/1996 SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 SIGMA DIAGNOSTICS, INC.
K963541 09/04/1996 SIGMA DIAGNOSTICS CO2 ACID REAGENT SIGMA DIAGNOSTICS, INC.
K954840 10/20/1995 ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 SIGMA DIAGNOSTICS, INC.
K954839 10/20/1995 ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV SIGMA DIAGNOSTICS, INC.
K003329 10/24/2000 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 SIGMA DIAGNOSTICS, INC.
K003328 10/24/2000 ACCUCLOT CONTROL I, MODEL A4089 SIGMA DIAGNOSTICS, INC.
K993741 11/04/1999 EZ LDL CHOLESTEROL TEST SYSTEM SIGMA DIAGNOSTICS, INC.
K955716 12/15/1995 VANCOMYCIN FPIA REAGENT SET SIGMA DIAGNOSTICS, INC.
K955735 12/18/1995 KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM SIGMA DIAGNOSTICS, INC.
K955724 12/18/1995 KC 1A COAGULATION ANALYZER/SET SIGMA DIAGNOSTICS, INC.
K955720 12/18/1995 AMAX CS-190 COAGULATION ANALYZER SYSTEM SIGMA DIAGNOSTICS, INC.
K984574 12/23/1998 INFINITY GLUCOSE REAGENT SIGMA DIAGNOSTICS, INC.
K010158 01/17/2001 THROMBOMAX-HS WITH CALCIUM, MODEL T6540 SIGMA DIAGNOSTICS, INC.
K010652 03/05/2001 SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 SIGMA DIAGNOSTICS, INC.
K021162 04/11/2002 AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED SIGMA DIAGNOSTICS, INC.
K012410 07/30/2001 INFINITY HBA KIT, MODELS 537-A, 537-B SIGMA DIAGNOSTICS, INC.
K003267 10/18/2000 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A SIGMA DIAGNOSTICS, INC.
K013549 10/24/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 SIGMA DIAGNOSTICS, INC.
K013545 10/24/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 SIGMA DIAGNOSTICS, INC.
K013544 10/24/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 SIGMA DIAGNOSTICS, INC.
K960875 03/04/1996 KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) SIGMA DIAGNOSTICS, INC.
K981248 04/06/1998 SIGMA DIAGNOSTICS ACCUCLOT CONTROL I SIGMA DIAGNOSTICS, INC.
K981254 04/06/1998 SIGMA DIAGNOSTICS ACCUCLOT CONTROL II SIGMA DIAGNOSTICS, INC.
K981255 04/06/1998 SIGMA DIAGNOSTICS ACCUCLOT CONTROL III SIGMA DIAGNOSTICS, INC.
K982209 06/23/1998 ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 SIGMA DIAGNOSTICS, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact