FDA 510(k) Applications Submitted by WILLIAM R GILBERT
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
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. |
K972132 |
06/06/1997 |
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS |
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. |
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. |
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. |
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. |
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. |
K003328 |
10/24/2000 |
ACCUCLOT CONTROL I, MODEL A4089 |
SIGMA DIAGNOSTICS, INC. |
K003329 |
10/24/2000 |
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 |
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. |
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