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

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

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

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