Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

E.I. Dupont DE Nemours & Co., Inc. · Predicate Candidate Screening

253 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

48 daysmedian FDA review time

103 days90th percentile

253clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K951851	ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMU	E.I. Dupont DE Nemours & Co., Inc.	1996-07-24	460	0
K953724	CRONEX RADIATION THERAPY CASSETTE	E.I. Dupont DE Nemours & Co., Inc.	1995-09-06	27	0
K953725	CRONEX RADIATION THERAPY VERIFICATION CASSETTE	E.I. Dupont DE Nemours & Co., Inc.	1995-09-06	27	0
K951441	DUPONT ACA DIGOXIN (DGN A) METHOD	E.I. Dupont DE Nemours & Co., Inc.	1995-06-01	64	0
K950137	URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-04-13	90	0
K950136	URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-04-05	82	0
K950181	URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-04-05	78	0
K950135	URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-03-30	76	0
K950134	URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-03-21	67	0
K950182	URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-03-21	63	0
K950427	URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-03-21	47	0
K950183	URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-03-20	62	0
K950180	DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD	E.I. Dupont DE Nemours & Co., Inc.	1995-03-15	57	0
K946153	DIGOXIN FLEX(TM) REAGENT CARTRIDGE	E.I. Dupont DE Nemours & Co., Inc.	1995-02-22	68	0
K950138	DRUGS OF ABUSE CONTROLS	E.I. Dupont DE Nemours & Co., Inc.	1995-02-22	40	0
K950139	DRUGS OF ABUSE CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1995-02-22	40	0
K944093	DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM	E.I. Dupont DE Nemours & Co., Inc.	1994-11-10	80	0
K934841	URINARY/CEREBROSPINAL FLUID PROTEIN	E.I. Dupont DE Nemours & Co., Inc.	1994-04-06	180	0
K935543	ACA PLUS FERRITIN CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1994-03-22	126	0
K934843	URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1994-03-11	154	0
K935528	DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH	E.I. Dupont DE Nemours & Co., Inc.	1994-01-28	73	0
K934144	DUPONT ACA URINE METHADONE CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1993-11-09	76	0
K934145	DUPONT ACA URINE METHADONE CONTROL	E.I. Dupont DE Nemours & Co., Inc.	1993-11-09	76	0
K934147	DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1993-11-09	76	0
K933955	DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTE	E.I. Dupont DE Nemours & Co., Inc.	1993-10-13	62	0
K931074	DU PONT MV DARKROOM CASSETTE	E.I. Dupont DE Nemours & Co., Inc.	1993-06-08	98	0
K931283	MICROVISION FAST DETAIL INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1993-06-08	88	0
K930489	AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS	E.I. Dupont DE Nemours & Co., Inc.	1993-05-12	103	0
K930162	ACA DIGOXIN ANALYTICAL TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1993-03-10	56	0
K925668	CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM	E.I. Dupont DE Nemours & Co., Inc.	1992-12-28	48	2
K924552	DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)	E.I. Dupont DE Nemours & Co., Inc.	1992-12-07	89	0
K923042	DU PONT LINX HD-25 LASR IMAGER	E.I. Dupont DE Nemours & Co., Inc.	1992-11-09	138	0
K922699	DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR	E.I. Dupont DE Nemours & Co., Inc.	1992-09-23	111	0
K922483	DU PONT COMPACT DAYLIGHT SYSTEM 2000	E.I. Dupont DE Nemours & Co., Inc.	1992-09-11	107	0
K922698	DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1992-09-09	97	0
K922701	DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD	E.I. Dupont DE Nemours & Co., Inc.	1992-09-09	97	0
K922680	DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT	E.I. Dupont DE Nemours & Co., Inc.	1992-08-20	77	0
K922700	DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.	E.I. Dupont DE Nemours & Co., Inc.	1992-08-20	77	0
K922696	DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO	E.I. Dupont DE Nemours & Co., Inc.	1992-08-12	69	0
K922697	DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD	E.I. Dupont DE Nemours & Co., Inc.	1992-08-10	67	0
K920190	ULTRA-VISION RAPID INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1992-05-28	134	0
K920200	ULTRA-VISION DETAIL INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1992-05-28	134	0
K920194	ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1992-05-27	133	0
K921455	ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD	E.I. Dupont DE Nemours & Co., Inc.	1992-04-29	33	0
K914917	DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1991-12-13	39	0
K914508	DIMENSION(R) LACTIC ACID METHOD	E.I. Dupont DE Nemours & Co., Inc.	1991-11-27	49	0
K914225	ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR	E.I. Dupont DE Nemours & Co., Inc.	1991-11-22	63	0
K914226	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1991-11-19	60	0
K911725	ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD	E.I. Dupont DE Nemours & Co., Inc.	1991-06-03	47	0
K911724	ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION	E.I. Dupont DE Nemours & Co., Inc.	1991-05-22	35	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda