Sigma Diagnostics, Inc.
St. Louis, MO, US
Sigma Diagnostics, Inc. appears in FDA device records in St. Louis, MO. FDA records list 164 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 164
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 164FDA records hold 164 510(k) clearances for Sigma Diagnostics, Inc. between 1984 and 2002. The busiest year on record is 1987, with 18. The most recent is 2002, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 4 |
| 1985 | 10 |
| 1986 | 16 |
| 1987 | 18 |
| 1988 | 11 |
| 1989 | 6 |
| 1990 | 1 |
| 1991 | 6 |
| 1992 | 5 |
| 1993 | 5 |
| 1994 | 18 |
| 1995 | 5 |
| 1996 | 18 |
| 1997 | 10 |
| 1998 | 8 |
| 1999 | 7 |
| 2000 | 5 |
| 2001 | 9 |
| 2002 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | JPA | Substantially Equivalent | |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | GGC | Substantially Equivalent | |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | DAP | Substantially Equivalent | |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | DAP | Substantially Equivalent | |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | DAP | Substantially Equivalent | |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | LCP | Substantially Equivalent | |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | JIX | Substantially Equivalent | |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | GGO | Substantially Equivalent | |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | DAP | Substantially Equivalent | |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | GGC | Substantially Equivalent | |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | GIZ | Substantially Equivalent | |
| K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | CFR | Substantially Equivalent | |
| K993741 | EZ LDL CHOLESTEROL TEST SYSTEM | MRR | Substantially Equivalent | |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | JFJ | Substantially Equivalent | |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | GIR | Substantially Equivalent | |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | GIR | Substantially Equivalent | |
| K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | GFO | Substantially Equivalent | |
| K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | GFO | Substantially Equivalent | |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | CIT | Substantially Equivalent | |
| K992800 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P | CDQ | Substantially Equivalent | |
| K992798 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P | CDO | Substantially Equivalent | |
| K992803 | SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP | CHH | Substantially Equivalent | |
| K984574 | INFINITY GLUCOSE REAGENT | CFR | Substantially Equivalent | |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | GJA | Substantially Equivalent | |
| K982251 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT | CDO | Substantially Equivalent | |
| K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | CDQ | Substantially Equivalent | |
| K981255 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL III | GGN | Substantially Equivalent | |
| K981254 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL II | GGN | Substantially Equivalent | |
| K981248 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL I | GGN | Substantially Equivalent | |
| K980667 | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) | CHH | Substantially Equivalent | |
| K980666 | INFINITY AST REAGENT (PROCEDURE NO. 51) | CIT | Substantially Equivalent | |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | GIZ | Substantially Equivalent | |
| K972260 | CS-400 COAGULATION ANALYZER SYSTEM (A1208) | JPA | Substantially Equivalent | |
| K972796 | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM | GJS | Substantially Equivalent | |
| K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | KQJ | Substantially Equivalent | |
| K972743 | SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT | CGX | Substantially Equivalent | |
| K972794 | DIGOXIN DG-II FPIA REAGENT SET | KXT | Substantially Equivalent | |
| K972132 | SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS | LEG | Substantially Equivalent | |
| K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | JBQ | Substantially Equivalent | |
| K972041 | EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) | LBS | Substantially Equivalent | |
| K963535 | SIGMA DIAGNOSTICS GLUCOSE REAGENT | CGA | Substantially Equivalent | |
| K963539 | SIGMA DIAGNOSTICS WASH CONCENTRATE | JJE | Substantially Equivalent | |
| K963543 | SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 | JIX | Substantially Equivalent | |
| K963533 | SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 | JIX | Substantially Equivalent | |
| K963541 | SIGMA DIAGNOSTICS CO2 ACID REAGENT | JFL | Substantially Equivalent | |
| K963537 | SIGMA DIAGNOSTICS BUN REAGENT | LFP | Substantially Equivalent | |
| K963538 | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | JFL | Substantially Equivalent | |
| K963536 | SIGMA DIAGNOSTICS CALICIUM REAGENT | CJY | Substantially Equivalent | |
| K963534 | SIGMA DIAGNOSTICS CREATININE REAGENT KIT | CGX | Substantially Equivalent | |
| K963542 | SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT | JGS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- IDFAcid, Fuchsin
- CDOAcid, Uric, Uricase (U.V.)
- GFOActivated Partial Thromboplastin
- DKCAlcohol Control Materials
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JBQAntithrombin Iii Quantitation
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JIWCalibrator, Surrogate
- DLJCalibrators, Drug Specific
- JFJCatalytic Methods, Amylase
- DDBCeruloplasmin, Antigen, Antiserum, Control
- JGYColorimetric Method, Triglycerides
- DIHColorimetry, Cholinesterase
- GGCControl, Plasma, Abnormal
- CICCresolphthalein Complexone, Calcium
- ICFCrystal Violet For Histology
- CIGDiazo Colorimetry, Bilirubin
- JGSElectrode, Ion Specific, Sodium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- CFRHexokinase, Glucose
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- HZAMethyl Green
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JFLPh Rate Measurement, Carbon-Dioxide
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- GILPlasma, Fibrinogen Control
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- GIRReagent, Russel Viper Venom
- GGOReagent, Thromboplastin And Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHRSystem, Test, Rheumatoid Factor
- GISTest, Fibrinogen
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
- JHNTurbidimetric Method, Lipoproteins
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- IACVan Gieson'S Stain
- IAFWright'S Stain
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain