FDA 510(k) Applications for Medical Device Product Code "DLZ"
(Enzyme Immunoassay, Phenobarbital)

FDA 510(k) Number Applicant Device Name Decision Date
K832457 ABBOTT LABORATORIES A-GENT PHENOBARBITAL 09/12/1983
K081231 ABBOTT LABORATORIES ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 09/26/2008
K833796 ABBOTT LABORATORIES CHEM KIT PHENOBARBITAL 01/30/1984
K860365 ALLIED INSTRUMENTATION LABORATORY PHENOBARBITAL TEST SYSTEM 03/17/1986
K935568 BAXTER DIAGNOSTICS, INC. PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS 03/11/1994
K802039 BECKMAN INSTRUMENTS, INC. PHENOBARBITAL REAGENT TEST KIT 10/23/1980
K860046 CLINICAL DATA, INC. DETERMINATION OF PHENOBARBITAL 01/22/1986
K000012 DIAGNOSTIC PRODUCTS CORP. IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 03/03/2000
K946210 DIAGNOSTIC REAGENTS, INC. PHENOBARBITAL ENZYME IMMUNOASSAY 02/10/1995
K944932 DUPONT MEDICAL PRODUCTS PHENOBARBITAL FLEX REAGENT CARTRIDGE 12/28/1994
K770919 E.I. DUPONT DE NEMOURS & CO., INC. PHENOBARBITAL ANALYTICAL TEST PACKS 06/22/1977
K862308 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 07/07/1986
K864926 EM DIAGNOSTIC SYSTEMS, INC. EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 01/07/1987
K852995 IMMUNOTECH CORP. ENDAB PHENOBARBITAL 08/12/1985
K910355 INSTRUMENTATION LABORATORY CO. IL PHENOBARBITAL ASSAY SYSTEM 04/03/1991
K943981 INSTRUMENTATION LABORATORY CO. IL TEST PHENOBARBITAL CALIBRATORS 01/18/1995
K811367 KALLESTAD LABORATORIES, INC. KALLESTAD ANTISERA TO PHENOBARBITAL 05/29/1981
K123271 MICROGENICS CORP. ABBOTT PHENOBARBITAL ASSAY 04/26/2013
K852946 MILES LABORATORIES, INC. SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT 09/30/1985
K984288 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS PHBR SLIDES 01/26/1999
K896861 PB DIAGNOSTIC SYSTEMS, INC. OPUS PHENOBARBITAL TEST SYSTEM 01/11/1990
K011303 RANDOX LABORATORIES, LTD. RANDOX PHENOBARBITAL 07/02/2001
K071644 ROCHE DIAGNOSTICS CORP. ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 09/12/2007
K942501 SCHIAPPARELLI BIOSYSTEMS, INC. ACE CEDIA PHENOBARBITAL ASSAY 10/06/1994
K993031 SYVA CO. ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 01/27/2000
K854607 SYVA CO. ACCULEVEL PHENOBARBITAL TEST 08/25/1986
K011528 SYVA CO. EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 06/06/2001
K874625 SYVA CO. EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY 12/22/1987
K834216 SYVA CO. EMIT QST PHENOBARBITAL ASSAY 01/24/1984
K913190 SYVA CO. EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS 08/26/1991
K811621 SYVA CO. EMIT-ST SERUM PHENOBARBITAL ASSAY 06/25/1981
K832097 SYVA CO. PHENOBARTIAL ASSAY USE ON COBAS-BIO 08/11/1983
K884419 TECHNICON INSTRUMENTS CORP. TECHNICON RA-PHENOBARBITAL 11/22/1988
K842264 VENTREX LABORATORIES, INC. VENTREZYME PHENOBARBITAL KIT IMMUNO 08/14/1984


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