E.I. Dupont de Nemours & Co., Inc.
Mchenry, IL, US
E.I. Dupont DE Nemours & Co., Inc. appears in FDA device records in Mchenry, IL. FDA records list 253 510(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
- 253
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 253FDA records hold 253 510(k) clearances for E.I. Dupont de Nemours & Co., Inc. between 1976 and 1996. The busiest year on record is 1984, with 30. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 14 |
| 1978 | 6 |
| 1979 | 7 |
| 1980 | 8 |
| 1981 | 13 |
| 1982 | 5 |
| 1983 | 23 |
| 1984 | 30 |
| 1985 | 20 |
| 1986 | 20 |
| 1987 | 14 |
| 1988 | 9 |
| 1989 | 10 |
| 1990 | 18 |
| 1991 | 9 |
| 1992 | 15 |
| 1993 | 8 |
| 1994 | 5 |
| 1995 | 15 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | LJO | Substantially Equivalent | |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | IXA | Substantially Equivalent | |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | IXA | Substantially Equivalent | |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | KXT | Substantially Equivalent | |
| K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE | DIS | Substantially Equivalent | |
| K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE | LDJ | Substantially Equivalent | |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | DJG | Substantially Equivalent | |
| K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE | DKZ | Substantially Equivalent | |
| K950427 | URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE | JXM | Substantially Equivalent | |
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | DIW | Substantially Equivalent | |
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | DLN | Substantially Equivalent | |
| K950183 | URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE | LCM | Substantially Equivalent | |
| K950180 | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD | DLI | Substantially Equivalent | |
| K950139 | DRUGS OF ABUSE CALIBRATOR | DKB | Substantially Equivalent | |
| K950138 | DRUGS OF ABUSE CONTROLS | DIF | Substantially Equivalent | |
| K946153 | DIGOXIN FLEX(TM) REAGENT CARTRIDGE | KXT | Substantially Equivalent | |
| K944093 | DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM | JJE | Substantially Equivalent | |
| K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN | CEK | Substantially Equivalent | |
| K935543 | ACA PLUS FERRITIN CALIBRATOR | JIX | Substantially Equivalent | |
| K934843 | URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR | JIT | Substantially Equivalent | |
| K935528 | DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH | DBF | Substantially Equivalent | |
| K934147 | DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK | DJR | Substantially Equivalent | |
| K934145 | DUPONT ACA URINE METHADONE CONTROL | LAS | Substantially Equivalent | |
| K934144 | DUPONT ACA URINE METHADONE CALIBRATOR | DLJ | Substantially Equivalent | |
| K933955 | DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM | JIX | Substantially Equivalent | |
| K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K931074 | DU PONT MV DARKROOM CASSETTE | IXA | Substantially Equivalent | |
| K930489 | AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS | JJE | Substantially Equivalent | |
| K930162 | ACA DIGOXIN ANALYTICAL TEST PACK | KXT | Substantially Equivalent | |
| K925668 | CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM | CGX | Substantially Equivalent | |
| K924552 | DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II) | IXW | Substantially Equivalent | |
| K923042 | DU PONT LINX HD-25 LASR IMAGER | LLZ | Substantially Equivalent | |
| K922699 | DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR | JIS | Substantially Equivalent | |
| K922483 | DU PONT COMPACT DAYLIGHT SYSTEM 2000 | KPX | Substantially Equivalent | |
| K922701 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD | JLW | Substantially Equivalent | |
| K922698 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR | JIS | Substantially Equivalent | |
| K922700 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. | JHY | Substantially Equivalent | |
| K922680 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT | JJE | Substantially Equivalent | |
| K922696 | DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO | JIS | Substantially Equivalent | |
| K922697 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD | JHI | Substantially Equivalent | |
| K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K920194 | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K921455 | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD | CFE | Substantially Equivalent | |
| K914917 | DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR | JIX | Substantially Equivalent | |
| K914508 | DIMENSION(R) LACTIC ACID METHOD | KHP | Substantially Equivalent | |
| K914225 | ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR | JZG | Substantially Equivalent | |
| K914226 | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | JZB | Substantially Equivalent | |
| K911725 | ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD | LCM | Substantially Equivalent | |
| K911724 | ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION | DIF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- JBQAntithrombin Iii Quantitation
- DCJBeta-Globulin, Antigen, Antiserum, Control
- CEKBiuret (Colorimetric), Total Protein
- JCOBothrops Atrox Reagent
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- IXACassette, Radiographic Film
- JFJCatalytic Methods, Amylase
- DLGCoating, Liquid, Glc
- DIHColorimetry, Cholinesterase
- DKJColorimetry, Salicylate
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CEMElectrode, Ion Specific, Potassium
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLFEnzyme Immunoassay, Ethosuximide
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- DLZEnzyme Immunoassay, Phenobarbital
- DJDEnzyme Immunoassay, Primidone
- DBFFerritin, Antigen, Antiserum, Control
- GHHFibrin Split Products
- GFXFibrinogen Standard
- IWZFilm, Radiographic
- DIRFree Radical Assay, Cocaine
- DKHGas Chromatography, Diphenylhydantoin
- DIWHemagglutination Inhibition, Methadone
- DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- GKFInstrument, Hematocrit, Automated
- DJYIon-Exchange Chromatography
- DOZLiquid Chromatography, Diphenylhydantoin
- JCFLymphocyte Separation Medium
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DDXPlasminogen, Antigen, Antiserum, Control
- IXWProcessor, Radiographic-Film, Automatic
- CIBRadioimmunoassay, Angiotensin I And Renin
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- EAMScreen, Intensifying, Radiographic
- FKXSystem, Peritoneal, Automatic Delivery
- DCNSystem, Test, C-Reactive Protein
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
- JGQTurbidimetric, Total Protein
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