Product code DLZ— Clinical Toxicology

FDA has cleared 35 devices under product code DLZ between 1977 and 2021, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20211 clearance
• 20131 clearance
• 20081 clearance
• 20071 clearance
• 20012 clearances
• 20002 clearances
• 19991 clearance
• 19952 clearances
• 19943 clearances
• 19912 clearances
• 19901 clearance
• 19881 clearance
• 19872 clearances
• 19864 clearances
• 19852 clearances

• Syva Co.8 clearances
• Abbott Laboratories3 clearances
• Ortho-Clinical Diagnostics, Inc.2 clearances
• Instrumentation Laboratory CO2 clearances
• Em Diagnostic Systems, Inc.2 clearances
• Ventrex Laboratories, Inc.1 clearance
• Technicon Instruments Corp.1 clearance
• Schiapparelli Biosystems, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Randox Laboratories, Ltd.1 clearance

• K210858 — VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.·2021-08-13
• K123271 — ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.·2013-04-26
• K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott Laboratories·2008-09-26
• K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.·2007-09-12
• K011303 — RANDOX PHENOBARBITALRandox Laboratories, Ltd.·2001-07-02
• K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.·2001-06-06
• K000012 — IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Diagnostic Products Corp.·2000-03-03
• K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS; MODELS 1E08 AND 5F54Syva Co.·2000-01-27
• K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDESOrtho-Clinical Diagnostics, Inc.·1999-01-26
• K946210 — PHENOBARBITAL ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.·1995-02-10
• K943981 — IL TEST PHENOBARBITAL CALIBRATORSInstrumentation Laboratory CO·1995-01-18
• K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGEDupont Medical Products·1994-12-28
• K942501 — ACE CEDIA PHENOBARBITAL ASSAYSchiapparelli Biosystems, Inc.·1994-10-06
• K935568 — PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORSBaxter Diagnostics, Inc.·1994-03-11
• K913190 — EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORSSyva Co.·1991-08-26
• K910355 — IL PHENOBARBITAL ASSAY SYSTEMInstrumentation Laboratory CO·1991-04-03
• K896861 — OPUS PHENOBARBITAL TEST SYSTEMPb Diagnostic Systems, Inc.·1990-01-11
• K884419 — TECHNICON RA-PHENOBARBITALTechnicon Instruments Corp.·1988-11-22
• K874625 — EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAYSyva Co.·1987-12-22
• K864926 — EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95Em Diagnostic Systems, Inc.·1987-01-07
• K854607 — ACCULEVEL PHENOBARBITAL TESTSyva Co.·1986-08-25
• K862308 — EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93Em Diagnostic Systems, Inc.·1986-07-07
• K860365 — PHENOBARBITAL TEST SYSTEMAllied Instrumentation Laboratory·1986-03-17
• K860046 — DETERMINATION OF PHENOBARBITALClinical Data, Inc.·1986-01-22
• K852946 — SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLTMiles Laboratories, Inc.·1985-09-30
• K852995 — ENDAB PHENOBARBITALImmunotech Corp.·1985-08-12
• K842264 — VENTREZYME PHENOBARBITAL KIT IMMUNOVentrex Laboratories, Inc.·1984-08-14
• K833796 — CHEM KIT PHENOBARBITALAbbott Laboratories·1984-01-30
• K834216 — EMIT QST PHENOBARBITAL ASSAYSyva Co.·1984-01-24
• K832457 — A-GENT PHENOBARBITALAbbott Laboratories·1983-09-12
• K832097 — PHENOBARTIAL ASSAY USE ON COBAS-BIOSyva Co.·1983-08-11
• K811621 — EMIT-ST SERUM PHENOBARBITAL ASSAYSyva Co.·1981-06-25
• K811367 — KALLESTAD ANTISERA TO PHENOBARBITALKallestad Laboratories, Inc.·1981-05-29
• K802039 — PHENOBARBITAL REAGENT TEST KITBeckman Instruments, Inc.·1980-10-23
• K770919 — PHENOBARBITAL ANALYTICAL TEST PACKSE.I. Dupont DE Nemours & Co., Inc.·1977-06-22