Product Code: DIP FDA class 2 21 CFR 862.3350

Enzyme Immunoassay, Diphenylhydantoin

Clinical Toxicology

The Enzyme Immunoassay for Diphenylhydantoin (phenytoin) is a laboratory assay that employs enzyme immunoassay methodology to quantify phenytoin, an anticonvulsant used in the management of epilepsy, in patient serum for therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3350 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DIP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DIP
Device Class: FDA class 2
Regulation Number: 862.3350
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K080696	ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01	Sep 11, 2008	Substantially Equivalent	Abbott Laboratories
K063145	PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS	Oct 17, 2007	Substantially Equivalent	Thermo Electron OY
K030428	ROCHE ONLINE TDM PHENYTOIN	Apr 28, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K011393	RANDOX PHENYTOIN	Dec 04, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K011347	EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229	May 17, 2001	Substantially Equivalent	Syva Co.
K000006	IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6	Feb 28, 2000	Substantially Equivalent	Diagnostic Products Corp.
K993026	ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS	Jan 27, 2000	Substantially Equivalent	Syva Co.
K973414	ACE PHENYTOIN REAGENT, AED CALIBRATORS	Nov 04, 1997	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K963840	CEDIA PHENYTOIN II ASSAY	Nov 20, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K943980	IL TEST PHENYTION CALIBRATORS	May 01, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K945725	PHENYTION EIA TEST	Feb 03, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K944085	ACE(TM) CEDIA(R) PHENYTOIN ASSAY	Dec 28, 1994	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K941142	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN	Jun 13, 1994	Substantially Equivalent	Eastman Kodak Company
K932686	PARAMAX(R) PHENYTOIN REAGENT	Nov 26, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K915755	BIOTRACK PHENYTOIN TEST CARTRIDGE	Jul 23, 1992	Substantially Equivalent	Biotrack, Inc.
K913429	EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS	Aug 26, 1991	Substantially Equivalent	Syva Co.
K911056	DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD	Apr 03, 1991	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K905689	CEDIA PHENYTOIN ASSAY	Jan 17, 1991	Substantially Equivalent	Microgenics Corp.
K904815	QMS TM- PHENYTOIN	Nov 06, 1990	Substantially Equivalent	Seradyn, Inc.
K902952	IL PHENYTOIN ASSAY SYSTEM	Aug 22, 1990	Substantially Equivalent	Instrumentation Laboratory CO
K901080	EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT	May 17, 1990	Substantially Equivalent	Immunotech Corp.
K896074	VISION PHENYTOIN	Nov 17, 1989	Substantially Equivalent	Abbott Laboratories
K874856	EMIT CONVENIENCE PACK: PHENYTOIN ASSAY	Jan 05, 1988	Substantially Equivalent	Syva Co.
K870953	PHENYTOIN FPIA REAGENT SET	Mar 31, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K864925	EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95	Jan 07, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K864554	EASY-TEST PRIMIDONE ITEM NO. 67---/95	Jan 07, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863403	PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS	Sep 29, 1986	Substantially Equivalent	Technicon Instruments Corp.
K855026	ACCULEVEL PHENYTOIN TEST	Aug 25, 1986	Substantially Equivalent	Syva / A Syntex Co.
K862349	EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93	Jul 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860286	IL TEST PHENYTOIN	Mar 05, 1986	Substantially Equivalent	Allied Instrumentation Laboratory
K860048	DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)	Jan 22, 1986	Substantially Equivalent	Clinical Data, Inc.
K850712	EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY	Mar 20, 1985	Substantially Equivalent	Syva Co.
K842092	SERALYZER ARIS PHENYTOIN REAGENT STRIPS	Mar 19, 1985	Substantially Equivalent	Miles Laboratories, Inc.
K844991	EMIT PHENYTOIN ASSAY	Jan 23, 1985	Substantially Equivalent	Syva Co.
K843209	PHENYTOIN ACA ANALYTICAL TEST PACK	Oct 11, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K842161	VENTREZYME PHENYTOIN KIT IMMUNOASSAY	Jul 09, 1984	Substantially Equivalent	Ventrex Laboratories, Inc.
K834406	EMIT QST PHENYTOIN ASSAY	Feb 03, 1984	Substantially Equivalent	Syva Co.
K833806	CHEMKIT PHENYTOIN DIAG. KIT	Jan 30, 1984	Substantially Equivalent	Abbott Laboratories
K832419	A-GENT PHERYTOIN	Sep 01, 1983	Substantially Equivalent	Abbott Laboratories
K832033	EMIT AED PHENYTOIN ASSAY	Aug 01, 1983	Substantially Equivalent	Syva Co.
K811745	VIRGO IPA FOR DETECTION OF PHENYTOIN	Jul 10, 1981	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K780218	ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE	Mar 03, 1978	Substantially Equivalent	Syva Co.
K772179	EMIT ANTIEPILEPTIC DRUG ASSAYS	Dec 20, 1977	Substantially Equivalent	Syva Co.
K771233	PHENYTOIN ANALYTICAL TEST PACKS	Jul 15, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.