Product Code: DLZ FDA class 2 21 CFR 862.3660

Enzyme Immunoassay, Phenobarbital

Clinical Toxicology

The Enzyme Immunoassay for Phenobarbital is a laboratory test system that uses enzyme-linked immunoassay techniques to measure phenobarbital, an anticonvulsant and sedative drug, in patient serum or plasma for therapeutic drug monitoring or toxicological assessment. It is a Class 2 device requiring 510(k) premarket notification. The product code is DLZ, regulated under 21 CFR 862.3660, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DLZ 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: DLZ
Device Class: FDA class 2
Regulation Number: 862.3660
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 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K210858	VITROS Chemistry Products PHBR Slides	Aug 13, 2021	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K123271	ABBOTT PHENOBARBITAL ASSAY	Apr 26, 2013	Substantially Equivalent	Microgenics Corp.
K081231	ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33	Sep 26, 2008	Substantially Equivalent	Abbott Laboratories
K071644	ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620	Sep 12, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K011303	RANDOX PHENOBARBITAL	Jul 02, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K011528	EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229	Jun 06, 2001	Substantially Equivalent	Syva Co.
K000012	IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5	Mar 03, 2000	Substantially Equivalent	Diagnostic Products Corp.
K993031	ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54	Jan 27, 2000	Substantially Equivalent	Syva Co.
K984288	VITROS CHEMISTRY PRODUCTS PHBR SLIDES	Jan 26, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K946210	PHENOBARBITAL ENZYME IMMUNOASSAY	Feb 10, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K943981	IL TEST PHENOBARBITAL CALIBRATORS	Jan 18, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K944932	PHENOBARBITAL FLEX REAGENT CARTRIDGE	Dec 28, 1994	Substantially Equivalent	Dupont Medical Products
K942501	ACE CEDIA PHENOBARBITAL ASSAY	Oct 06, 1994	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K935568	PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS	Mar 11, 1994	Substantially Equivalent	Baxter Diagnostics, Inc.
K913190	EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS	Aug 26, 1991	Substantially Equivalent	Syva Co.
K910355	IL PHENOBARBITAL ASSAY SYSTEM	Apr 03, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K896861	OPUS PHENOBARBITAL TEST SYSTEM	Jan 11, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K884419	TECHNICON RA-PHENOBARBITAL	Nov 22, 1988	Substantially Equivalent	Technicon Instruments Corp.
K874625	EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY	Dec 22, 1987	Substantially Equivalent	Syva Co.
K864926	EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95	Jan 07, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K854607	ACCULEVEL PHENOBARBITAL TEST	Aug 25, 1986	Substantially Equivalent	Syva Co.
K862308	EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93	Jul 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860365	PHENOBARBITAL TEST SYSTEM	Mar 17, 1986	Substantially Equivalent	Allied Instrumentation Laboratory
K860046	DETERMINATION OF PHENOBARBITAL	Jan 22, 1986	Substantially Equivalent	Clinical Data, Inc.
K852946	SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT	Sep 30, 1985	Substantially Equivalent	Miles Laboratories, Inc.
K852995	ENDAB PHENOBARBITAL	Aug 12, 1985	Substantially Equivalent	Immunotech Corp.
K842264	VENTREZYME PHENOBARBITAL KIT IMMUNO	Aug 14, 1984	Substantially Equivalent	Ventrex Laboratories, Inc.
K833796	CHEM KIT PHENOBARBITAL	Jan 30, 1984	Substantially Equivalent	Abbott Laboratories
K834216	EMIT QST PHENOBARBITAL ASSAY	Jan 24, 1984	Substantially Equivalent	Syva Co.
K832457	A-GENT PHENOBARBITAL	Sep 12, 1983	Substantially Equivalent	Abbott Laboratories
K832097	PHENOBARTIAL ASSAY USE ON COBAS-BIO	Aug 11, 1983	Substantially Equivalent	Syva Co.
K811621	EMIT-ST SERUM PHENOBARBITAL ASSAY	Jun 25, 1981	Substantially Equivalent	Syva Co.
K811367	KALLESTAD ANTISERA TO PHENOBARBITAL	May 29, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K802039	PHENOBARBITAL REAGENT TEST KIT	Oct 23, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K770919	PHENOBARBITAL ANALYTICAL TEST PACKS	Jun 22, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.