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

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
253
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYJuly 24, 1996
K953725CRONEX RADIATION THERAPY VERIFICATION CASSETTESeptember 6, 1995
K953724CRONEX RADIATION THERAPY CASSETTESeptember 6, 1995
K951441DUPONT ACA DIGOXIN (DGN A) METHODJune 1, 1995
K950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEApril 13, 1995
K950181URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGEApril 5, 1995
K950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGEApril 5, 1995
K950135URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGEMarch 30, 1995
K950182URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGEMarch 21, 1995
K950134URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGEMarch 21, 1995
K950427URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGEMarch 21, 1995
K950183URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGEMarch 20, 1995
K950180DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHODMarch 15, 1995
K950138DRUGS OF ABUSE CONTROLSFebruary 22, 1995
K950139DRUGS OF ABUSE CALIBRATORFebruary 22, 1995
K946153DIGOXIN FLEX(TM) REAGENT CARTRIDGEFebruary 22, 1995
K944093DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEMNovember 10, 1994
K934841URINARY/CEREBROSPINAL FLUID PROTEINApril 6, 1994
K935543ACA PLUS FERRITIN CALIBRATORMarch 22, 1994
K934843URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATORMarch 11, 1994