Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
164 devices
Cleared
Aug 05, 1998
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
Chemistry
41d
Cleared
Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
Hematology
23d
Cleared
Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
Hematology
23d
Cleared
Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
Hematology
23d
Cleared
Apr 21, 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
Chemistry
60d
Cleared
Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
Chemistry
28d
Cleared
Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
Hematology
59d
Cleared
Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
Hematology
125d
Cleared
Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
Hematology
74d
Cleared
Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
Hematology
142d
Cleared
Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
Chemistry
61d
Cleared
Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
Toxicology
55d
Cleared
Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC...
Toxicology
54d
Cleared
Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
Hematology
49d
Cleared
Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
Chemistry
50d
Cleared
Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
Chemistry
135d
Cleared
Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
Chemistry
103d
Cleared
Oct 30, 1996
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
Chemistry
56d
Cleared
Oct 29, 1996
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
Chemistry
55d
Cleared
Oct 24, 1996
SIGMA DIAGNOSTICS BUN REAGENT
Chemistry
50d
Cleared
Oct 24, 1996
SIGMA DIAGNOSTICS CO2 ACID REAGENT
Chemistry
50d
Cleared
Oct 11, 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
Chemistry
37d
Cleared
Oct 10, 1996
SIGMA DIAGNOSTICS CALICIUM REAGENT
Chemistry
37d
Cleared
Sep 30, 1996
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
Chemistry
26d
Cleared
Sep 27, 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
Chemistry
23d
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