Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
164 devices
Cleared
Sep 27, 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
Chemistry
23d
Cleared
Sep 10, 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
Hematology
190d
Cleared
Mar 13, 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
Hematology
86d
Cleared
Mar 12, 1996
KC 1A COAGULATION ANALYZER/SET
Hematology
85d
Cleared
Mar 11, 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
Hematology
84d
Cleared
Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
Chemistry
131d
Cleared
Feb 16, 1996
VANCOMYCIN FPIA REAGENT SET
Toxicology
63d
Cleared
Jan 24, 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
Chemistry
236d
Cleared
Jan 05, 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
Chemistry
77d
Cleared
Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
Chemistry
127d
Cleared
Jun 29, 1995
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
Hematology
687d
Cleared
May 08, 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
Chemistry
157d
Cleared
Mar 21, 1995
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
Toxicology
76d
Cleared
Jan 20, 1995
IGM RF EIA
Immunology
213d
Cleared
Dec 02, 1994
ANTI DS-DNA
Immunology
147d
Cleared
Nov 17, 1994
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
Toxicology
119d
Cleared
Nov 10, 1994
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
Chemistry
94d
Cleared
Nov 10, 1994
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
Chemistry
83d
Cleared
Nov 10, 1994
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
Chemistry
64d
Cleared
Oct 27, 1994
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
Toxicology
108d
Cleared
Jul 20, 1994
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
Chemistry
218d
Cleared
Jul 19, 1994
ACT CONTROL SET
Hematology
146d
Cleared
Jul 13, 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
Chemistry
155d
Cleared
Jul 13, 1994
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
Chemistry
70d
Cleared
Jun 02, 1994
APOLIPOPROTIEN B (APO B)
Chemistry
370d
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