DIP · Class II · 21 CFR 862.3350

FDA Product Code DIP: Enzyme Immunoassay, Diphenylhydantoin

Leading manufacturers include Syva Co., Abbott Laboratories and E.I. Dupont DE Nemours & Co., Inc..

44
Total
44
Cleared
83d
Avg days
1977
Since

FDA 510(k) Cleared Enzyme Immunoassay, Diphenylhydantoin Devices (Product Code DIP)

44 devices
1–24 of 44
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
K080696
Abbott Laboratories
Toxicology · 183d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428
Roche Diagnostics Corp.
Toxicology · 77d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347
Syva Co.
Toxicology · 15d
Cleared Feb 28, 2000
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
K000006
Diagnostic Products Corp.
Toxicology · 56d
Cleared Jan 27, 2000
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026
Syva Co.
Toxicology · 140d
Cleared Nov 20, 1996
CEDIA PHENYTOIN II ASSAY
K963840
Boehringer Mannheim Corp.
Toxicology · 57d
Cleared May 01, 1995
IL TEST PHENYTION CALIBRATORS
K943980
Instrumentation Laboratory CO
Toxicology · 328d
Cleared Jun 13, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142
Eastman Kodak Company
Chemistry · 95d
Cleared Aug 26, 1991
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
K913429
Syva Co.
Toxicology · 25d
Cleared Apr 03, 1991
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
K911056
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Aug 22, 1990
IL PHENYTOIN ASSAY SYSTEM
K902952
Instrumentation Laboratory CO
Toxicology · 48d
Cleared Nov 17, 1989
VISION PHENYTOIN
K896074
Abbott Laboratories
Chemistry · 29d
Cleared Jan 05, 1988
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856
Syva Co.
Toxicology · 41d
Cleared Jan 07, 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554
Em Diagnostic Systems, Inc.
Toxicology · 49d
Cleared Jan 07, 1987
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
K864925
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
K862349
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Mar 20, 1985
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY
K850712
Syva Co.
Toxicology · 26d
Cleared Jan 23, 1985
EMIT PHENYTOIN ASSAY
K844991
Syva Co.
Toxicology · 28d
Cleared Oct 11, 1984
PHENYTOIN ACA ANALYTICAL TEST PACK
K843209
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 57d
Cleared Feb 03, 1984
EMIT QST PHENYTOIN ASSAY
K834406
Syva Co.
Toxicology · 51d
Cleared Jan 30, 1984
CHEMKIT PHENYTOIN DIAG. KIT
K833806
Abbott Laboratories
Toxicology · 90d
Cleared Sep 01, 1983
A-GENT PHERYTOIN
K832419
Abbott Laboratories
Toxicology · 41d
Cleared Aug 01, 1983
EMIT AED PHENYTOIN ASSAY
K832033
Syva Co.
Chemistry · 39d
Cleared Mar 03, 1978
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE
K780218
Syva Co.
Toxicology · 21d

About Product Code DIP - Regulatory Context