DIP · Class II · 21 CFR 862.3350

FDA Product Code DIP: Enzyme Immunoassay, Diphenylhydantoin

Leading manufacturers include Syva Co., Abbott Laboratories and Em Diagnostic Systems, Inc..

44
Total
44
Cleared
83d
Avg days
1977
Since
44 devices
25–44 of 44
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