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
44 devices
25–44 of 44
Cleared Sep 29, 1986
PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS
K863403
Technicon Instruments Corp.
Toxicology · 26d
Cleared Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
K862349
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jan 22, 1986
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
K860048
Clinical Data, Inc.
Toxicology · 16d
Cleared Mar 20, 1985
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY
K850712
Syva Co.
Toxicology · 26d
Cleared Mar 19, 1985
SERALYZER ARIS PHENYTOIN REAGENT STRIPS
K842092
Miles Laboratories, Inc.
Toxicology · 299d
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 Jul 09, 1984
VENTREZYME PHENYTOIN KIT IMMUNOASSAY
K842161
Ventrex Laboratories, Inc.
Chemistry · 40d
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 Jul 10, 1981
VIRGO IPA FOR DETECTION OF PHENYTOIN
K811745
Electro-Nucleonics Laboratories, Inc.
Toxicology · 21d
Cleared Mar 03, 1978
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE
K780218
Syva Co.
Toxicology · 21d
Cleared Dec 20, 1977
EMIT ANTIEPILEPTIC DRUG ASSAYS
K772179
Syva Co.
Toxicology · 27d
Cleared Jul 15, 1977
PHENYTOIN ANALYTICAL TEST PACKS
K771233
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 8d