Beckman Instruments, Inc.
Mchenry, IL, US
Beckman Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 281 510(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
- 281
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 281FDA records hold 281 510(k) clearances for Beckman Instruments, Inc. between 1976 and 1998. The busiest year on record is 1997, with 43. The most recent is 1998, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 11 |
| 1977 | 19 |
| 1978 | 18 |
| 1979 | 14 |
| 1980 | 22 |
| 1981 | 19 |
| 1982 | 13 |
| 1983 | 8 |
| 1984 | 10 |
| 1985 | 6 |
| 1986 | 7 |
| 1987 | 8 |
| 1988 | 5 |
| 1989 | 7 |
| 1990 | 6 |
| 1991 | 8 |
| 1992 | 7 |
| 1993 | 7 |
| 1994 | 11 |
| 1995 | 12 |
| 1996 | 13 |
| 1997 | 43 |
| 1998 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | LGD | Substantially Equivalent | |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CEC | Substantially Equivalent | |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | DKB | Substantially Equivalent | |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | LOJ | Substantially Equivalent | |
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | JHI | Substantially Equivalent | |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | LTJ | Substantially Equivalent | |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | DEB | Substantially Equivalent | |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | JBQ | Substantially Equivalent | |
| K974452 | VIGIL LIPID CONTROL | JJY | Substantially Equivalent | |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | JIX | Substantially Equivalent | |
| K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) | JIX | Substantially Equivalent | |
| K974050 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT | DCK | Substantially Equivalent | |
| K973696 | SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT | LCP | Substantially Equivalent | |
| K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | JZG | Substantially Equivalent | |
| K974075 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | MMI | Substantially Equivalent | |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CDP | Substantially Equivalent | |
| K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | CHP | Substantially Equivalent | |
| K973069 | SYNCHRON SYSTEMS METHADONE REAGENT | DJR | Substantially Equivalent | |
| K971958 | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT | DDG | Substantially Equivalent | |
| K972819 | VIGIL TDM CONTROLS | DIF | Substantially Equivalent | |
| K971602 | ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT | DHR | Substantially Equivalent | |
| K971505 | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT | CHH | Substantially Equivalent | |
| K964842 | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT | CZW | Substantially Equivalent | |
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | CHI | Substantially Equivalent | |
| K971788 | SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR | DHR | Substantially Equivalent | |
| K971506 | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR | DMT | Substantially Equivalent | |
| K971283 | SYNCHRON SYSTEMS CAL 5 PLUS | JIX | Substantially Equivalent | |
| K971333 | SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD | JIX | Substantially Equivalent | |
| K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | KNK | Substantially Equivalent | |
| K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT | KLI | Substantially Equivalent | |
| K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | DDS | Substantially Equivalent | |
| K971287 | SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS | DKB | Substantially Equivalent | |
| K964695 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT | DCF | Substantially Equivalent | |
| K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | DEM | Substantially Equivalent | |
| K964762 | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT | DDB | Substantially Equivalent | |
| K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | MSJ | Substantially Equivalent | |
| K965033 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT | MGA | Substantially Equivalent | |
| K971210 | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS | LAS | Substantially Equivalent | |
| K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | JIQ | Substantially Equivalent | |
| K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | LKL | Substantially Equivalent | |
| K963976 | IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT | DDG | Substantially Equivalent | |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L | JJE | Substantially Equivalent | |
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT | DEW | Substantially Equivalent | |
| K964843 | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT | JZH | Substantially Equivalent | |
| K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN | DEW | Substantially Equivalent | |
| K964009 | IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS | DNO | Substantially Equivalent | |
| K964260 | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG | DFH | Substantially Equivalent | |
| K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | MSJ | Substantially Equivalent | |
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) | DEW | Substantially Equivalent | |
| K963673 | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS | KLT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- CJAAmyloclastic, Amylase
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DIDBacillus Subtilis Microbiology Assay, Tobramycin
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DDBCeruloplasmin, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- BZLComputer, Oxygen-Uptake
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CDSElectrode, Ion Specific, Urea Nitrogen
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- CEFElectrophoretic, Protein Fractionation
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DLZEnzyme Immunoassay, Phenobarbital
- DJDEnzyme Immunoassay, Primidone
- DBFFerritin, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DGOIge, Peroxidase, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CECRadioimmunoassay, Free Thyroxine
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDPRadioimmunoassay, Total Triiodothyronine
- CIJSaccharogenic, Amylase
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- DGRWhole Human Serum, Antigen, Antiserum, Control
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