Medical Device Manufacturer · US , Wilmington , DE

Dupont Medical Products - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1991
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dupont Medical Products Chemistry
18 devices
1-18 of 18
Cleared Aug 31, 1995
DUPONT LIPASE CALIBRATOR
K952815 · JIT
Chemistry · 72d
Cleared Aug 11, 1995
DUPONT DIMENSION TOTAL PROTEIN METHOD
K950920 · CEK
Chemistry · 163d
Cleared Jul 20, 1995
LIPASE FLEX REAGENT CARTRIDGE
K952816 · CHI
Chemistry · 30d
Cleared Nov 10, 1994
DUPONT ACA STAR
K941050 · JJQ
Chemistry · 248d
Cleared Oct 03, 1994
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
K941146 · JLW
Chemistry · 207d
Cleared Sep 09, 1994
DUPONT DIMENSION AMYLASE METHOD
K942640 · JFJ
Chemistry · 98d
Cleared Aug 18, 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN
K942241 · JKA
Chemistry · 101d
Cleared Aug 17, 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN
K942240 · JKA
Chemistry · 100d
Cleared Aug 09, 1994
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
K941219 · JIX
Chemistry · 148d
Cleared Aug 02, 1994
KINASE ISOENZYME
K943024 · JHS
Chemistry · 68d
Cleared Jul 20, 1994
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
K941221 · CGJ
Chemistry · 128d
Cleared Jul 06, 1994
CREATINE KINASE METHOD
K941584 · JHS
Chemistry · 96d
Cleared Jun 03, 1994
DUPONT ACA PLUS PROLACTIN (PROL) METHOD
K941220 · CFT
Chemistry · 81d
Cleared May 09, 1994
URINARY ALBUMIN TEST PACK
K936202 · JIQ
Chemistry · 131d
Cleared Mar 11, 1994
URINARY ALBUMIN CALIBRATOR
K936201 · JIS
Chemistry · 72d
Cleared Aug 09, 1993
DU PONT ACA NEV/EEV VERIFIER
K930501 · JIS
Chemistry · 189d
Cleared Jul 27, 1993
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
K932044 · CEM
Chemistry · 91d
Cleared Jan 28, 1992
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
K915106 · JJE
Chemistry · 76d
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