Medical Device Manufacturer · US , Mchenry , IL

Sigma Chemical Co.

231 submissions · 231 cleared · Since 1976
231
Total
231
Cleared
0
Denied

Sigma Chemical Co. — FDA 510(k) Submissions

Sigma Chemical Co. has submitted 231 FDA 510(k) premarket notifications since 1976, of which 231 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media And Components, Synthetic Cell And Tissue Culture, Test, Qualitative And Quantitative Factor Deficiency, Plasma, Coagulation Factor Deficient, Ph Rate Measurement, Carbon-dioxide, Enzymatic Esterase--oxidase, Cholesterol . Use the specialty filter in the sidebar to narrow results.

231 devices
1–25 of 231
SIGMA GLUCOSE REAGENT
K933694 · CGA Glucose Oxidase, Glucose · Chemistry
Nov 1994 463d
SIGMA CALCIUM REAGENT
K933678 · CJY Azo Dye, Calcium · Chemistry
Mar 1994 225d
SIGMA ELECTROLYTE REFERENCE REAGENT
K933696 · JFL Ph Rate Measurement,... · Chemistry
Jan 1994 158d
SIGMA BUN REAGENT
K933679 · LFP Conductivity Rate, Urea... · Chemistry
Dec 1993 142d
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691 · JFL Ph Rate Measurement,... · Chemistry
Dec 1993 141d
SIGMA WASH CONCENTRATE SOLUTION
K933703 · JJE Analyzer, Chemistry... · Chemistry
Dec 1993 134d
SIGMA CO2 ACID REAGENT
K933692 · JFL Ph Rate Measurement,... · Chemistry
Dec 1993 133d
SIGMA ELECTROLYTE BUFFER
K933695 · JFL Ph Rate Measurement,... · Chemistry
Oct 1993 85d
SIGMA CRE REAGENT
K933697 · CGX Alkaline Picrate,... · Chemistry
Oct 1993 81d
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
K933693 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 1993 76d
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
K933702 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 1993 71d
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · JLW Radioimmunoassay,... · Chemistry
Aug 1993 226d
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · GKZ Counter, Differential Cell · Hematology
Oct 1991 597d
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · GKZ Counter, Differential Cell · Hematology
Oct 1991 597d
MONOCLONAL ANTIBODY ANTI-CD5
K901188 · GKZ Counter, Differential Cell · Hematology
Oct 1991 597d
MONOCLONAL ANTIBODY ANTI-CD3
K901189 · GKZ Counter, Differential Cell · Hematology
Oct 1991 597d
NITRO BLUE TETRAZOLIUM REDUCTION
K904022 · GHD Test, Leukocyte Alkaline... · Pathology
Dec 1990 110d
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
K903995 · GHD Test, Leukocyte Alkaline... · Pathology
Dec 1990 106d
APTT REAGENT
K904341 · GFO Activated Partial... · Hematology
Nov 1990 49d
CHOLESTEROL (RATE) REAGENT
K902098 · CHH Enzymatic... · Chemistry
Aug 1990 93d
COAGULATION CONTROL, LEVEL I
K902361 · GGN Plasma, Coagulation Control · Hematology
Jul 1990 58d
COAGULATION CONTROL, LEVEL II
K902362 · GGN Plasma, Coagulation Control · Hematology
Jul 1990 58d
COAGULATION CONTROL, LEVEL III
K902363 · GGN Plasma, Coagulation Control · Hematology
Jul 1990 58d
THROMBOPLASTIN WITH CALCIUM
K902096 · GJS Test, Time, Prothrombin · Hematology
Jul 1990 56d
ACCUSCAN MICROBEAD STANDARDS
K902294 · JIW Calibrator, Surrogate · Hematology
Jul 1990 42d

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