Company ยท US
E.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1996. Name variants (Inc, Corp, punctuation) are merged.
253510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DLJ | Calibrators, Drug Specific | 21 |
| EAM | Screen, Intensifying, Radiographic | 11 |
| JIT | Calibrator, Secondary | 10 |
| JIS | Calibrator, Primary | 8 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 |
| IXA | Cassette, Radiographic Film | 6 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 5 |
| JIX | Calibrator, Multi-Analyte Mixture | 5 |
| KXT | Enzyme Immunoassay, Digoxin | 5 |
| DJY | Ion-Exchange Chromatography | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 3 |
| DIF | Drug Mixture Control Materials | 3 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 |
| DKB | Calibrators, Drug Mixture | 3 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 3 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 3 |
| KLB | Radioimmunoassay, Tobramycin | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 1996 | K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY E.I. Dupont DE Nemours & Co., Inc. | LJO |
| Sep 6, 1995 | K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE E.I. Dupont DE Nemours & Co., Inc. | IXA |
| Sep 6, 1995 | K953724 | CRONEX RADIATION THERAPY CASSETTE E.I. Dupont DE Nemours & Co., Inc. | IXA |
| Jun 1, 1995 | K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Apr 13, 1995 | K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DIS |
| Apr 5, 1995 | K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | LDJ |
| Apr 5, 1995 | K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DJG |
| Mar 30, 1995 | K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DKZ |
| Mar 21, 1995 | K950427 | URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | JXM |
| Mar 21, 1995 | K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DIW |
| Mar 21, 1995 | K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE E.I. Dupont DE Nemours & Co., Inc. | DLN |
| Mar 20, 1995 | K950183 | URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | LCM |
| Mar 15, 1995 | K950180 | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD E.I. Dupont DE Nemours & Co., Inc. | DLI |
| Feb 22, 1995 | K950139 | DRUGS OF ABUSE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DKB |
| Feb 22, 1995 | K950138 | DRUGS OF ABUSE CONTROLS E.I. Dupont DE Nemours & Co., Inc. | DIF |
| Feb 22, 1995 | K946153 | DIGOXIN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Nov 10, 1994 | K944093 | DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. | JJE |
| Apr 6, 1994 | K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN E.I. Dupont DE Nemours & Co., Inc. | CEK |
| Mar 22, 1994 | K935543 | ACA PLUS FERRITIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIX |
| Mar 11, 1994 | K934843 | URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIT |
| Jan 28, 1994 | K935528 | DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH E.I. Dupont DE Nemours & Co., Inc. | DBF |
| Nov 9, 1993 | K934147 | DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK E.I. Dupont DE Nemours & Co., Inc. | DJR |
| Nov 9, 1993 | K934145 | DUPONT ACA URINE METHADONE CONTROL E.I. Dupont DE Nemours & Co., Inc. | LAS |
| Nov 9, 1993 | K934144 | DUPONT ACA URINE METHADONE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DLJ |
| Oct 13, 1993 | K933955 | DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. | JIX |
| Jun 8, 1993 | K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Jun 8, 1993 | K931074 | DU PONT MV DARKROOM CASSETTE E.I. Dupont DE Nemours & Co., Inc. | IXA |
| May 12, 1993 | K930489 | AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS E.I. Dupont DE Nemours & Co., Inc. | JJE |
| Mar 10, 1993 | K930162 | ACA DIGOXIN ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Dec 28, 1992 | K925668 | CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM E.I. Dupont DE Nemours & Co., Inc. | CGX |
| Dec 7, 1992 | K924552 | DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II) E.I. Dupont DE Nemours & Co., Inc. | IXW |
| Nov 9, 1992 | K923042 | DU PONT LINX HD-25 LASR IMAGER E.I. Dupont DE Nemours & Co., Inc. | LLZ |
| Sep 23, 1992 | K922699 | DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Sep 11, 1992 | K922483 | DU PONT COMPACT DAYLIGHT SYSTEM 2000 E.I. Dupont DE Nemours & Co., Inc. | KPX |
| Sep 9, 1992 | K922701 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD E.I. Dupont DE Nemours & Co., Inc. | JLW |
| Sep 9, 1992 | K922698 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Aug 20, 1992 | K922700 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. E.I. Dupont DE Nemours & Co., Inc. | JHY |
| Aug 20, 1992 | K922680 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT E.I. Dupont DE Nemours & Co., Inc. | JJE |
| Aug 12, 1992 | K922696 | DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Aug 10, 1992 | K922697 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD E.I. Dupont DE Nemours & Co., Inc. | JHI |
| May 28, 1992 | K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| May 28, 1992 | K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| May 27, 1992 | K920194 | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Apr 29, 1992 | K921455 | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD E.I. Dupont DE Nemours & Co., Inc. | CFE |
| Dec 13, 1991 | K914917 | DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIX |
| Nov 27, 1991 | K914508 | DIMENSION(R) LACTIC ACID METHOD E.I. Dupont DE Nemours & Co., Inc. | KHP |
| Nov 22, 1991 | K914225 | ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JZG |
| Nov 19, 1991 | K914226 | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK E.I. Dupont DE Nemours & Co., Inc. | JZB |
| Jun 3, 1991 | K911725 | ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD E.I. Dupont DE Nemours & Co., Inc. | LCM |
| May 22, 1991 | K911724 | ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION E.I. Dupont DE Nemours & Co., Inc. | DIF |
Newest 50 of 253.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||