Sigma Chemical Co. - FDA 510(k) Cleared Devices
231
Total
231
Cleared
0
Denied
231 devices
Cleared
Apr 26, 1990
APOLIPOPROTEIN A-I (APO A-I)
Immunology
16d
Cleared
Mar 06, 1990
FACTOR V DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR VII DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR VIII DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR IX DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR X DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR XI DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR XII DEFICIENT PLASMA
Hematology
36d
Cleared
Mar 06, 1990
FACTOR II DEFICIENT PLASMA
Hematology
7d
Cleared
Mar 02, 1990
APOLIPOPROTEIN B (APO B)
Immunology
52d
Cleared
Feb 13, 1990
CO2 REAGENT (340 NM)
Chemistry
106d
Cleared
Feb 08, 1990
AMYLASE REAGENT
Chemistry
76d
Cleared
Dec 01, 1989
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
Hematology
14d
Cleared
Nov 09, 1989
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
Hematology
21d
Cleared
Sep 05, 1989
THROMBIN TIME REAGENT
Hematology
49d
Cleared
Jul 20, 1989
ALT REAGENT (PROCEDURE NUMBER 159)
Chemistry
72d
Cleared
Jun 23, 1989
URIC ACID REAGENT (PROCEDURE NUMBER 686)
Chemistry
52d
Cleared
Jun 20, 1989
AST REAGENT (PROCEDURE NUMBER 158)
Chemistry
63d
Cleared
Mar 28, 1989
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
Chemistry
96d
Cleared
Mar 09, 1989
TOTAL PROTEIN REAGENT
Chemistry
50d
Cleared
Nov 22, 1988
RPMI-1640 HYBRI-MAX, PROD. NO. R5382
Pathology
21d
Cleared
Nov 22, 1988
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891
Pathology
21d
Cleared
Nov 22, 1988
DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785
Pathology
21d
Cleared
Nov 10, 1988
MAGNESIUM REAGENT (MAGON SULFONATE)
Chemistry
51d
Cleared
Oct 25, 1988
OXALATE REAGENT
Chemistry
69d
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