Medical Device Manufacturer · US , Mchenry , IL

E.I. Dupont DE Nemours & Co., Inc.

253 submissions · 252 cleared · Since 1976
253
Total
252
Cleared
0
Denied

E.I. Dupont DE Nemours & Co., Inc. — FDA 510(k) Submissions

E.I. Dupont DE Nemours & Co., Inc. has submitted 253 FDA 510(k) premarket notifications since 1976, of which 252 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrators, Drug Specific, Screen, Intensifying, Radiographic, Calibrator, Secondary, Calibrator, Primary, Analyzer, Chemistry (photometric, Discrete), For Clinical Use . Use the specialty filter in the sidebar to narrow results.

253 devices
1–25 of 253
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851 · LJO Antigen, Iha,... · Microbiology
Jul 1996 460d
CRONEX RADIATION THERAPY CASSETTE
K953724 · IXA Cassette, Radiographic Film · Radiology
Sep 1995 27d
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · IXA Cassette, Radiographic Film · Radiology
Sep 1995 27d
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Jun 1995 64d
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950137 · DIS Enzyme Immunoassay,... · Toxicology
Apr 1995 90d
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · DJG Enzyme Immunoassay, Opiates · Toxicology
Apr 1995 82d
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 · LDJ Enzyme Immunoassay,... · Toxicology
Apr 1995 78d
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135 · DKZ Enzyme Immunoassay,... · Toxicology
Mar 1995 76d
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
K950134 · DLN Hemagglutination, Cocaine... · Toxicology
Mar 1995 67d
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950182 · DIW Hemagglutination... · Toxicology
Mar 1995 63d
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · JXM Enzyme Immunoassay,... · Toxicology
Mar 1995 47d
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950183 · LCM Enzyme Immunoassay,... · Toxicology
Mar 1995 62d
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
K950180 · DLI Acetylcholine Chloride,... · Toxicology
Mar 1995 57d
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Feb 1995 68d
DRUGS OF ABUSE CONTROLS
K950138 · DIF Drug Mixture Control... · Toxicology
Feb 1995 40d
DRUGS OF ABUSE CALIBRATOR
K950139 · DKB Calibrators, Drug Mixture · Toxicology
Feb 1995 40d
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
K944093 · JJE Analyzer, Chemistry... · Chemistry
Nov 1994 80d
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841 · CEK Biuret (colorimetric),... · Chemistry
Apr 1994 180d
ACA PLUS FERRITIN CALIBRATOR
K935543 · JIX Calibrator, Multi-analyte... · Chemistry
Mar 1994 126d
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843 · JIT Calibrator, Secondary · Chemistry
Mar 1994 154d
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528 · DBF Ferritin, Antigen,... · Immunology
Jan 1994 73d
DUPONT ACA URINE METHADONE CALIBRATOR
K934144 · DLJ Calibrators, Drug Specific · Toxicology
Nov 1993 76d
DUPONT ACA URINE METHADONE CONTROL
K934145 · LAS Drug Specific Control... · Toxicology
Nov 1993 76d
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · DJR Enzyme Immunoassay,... · Toxicology
Nov 1993 76d
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
K933955 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 1993 62d

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