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
K081231	ABBOTT LABORATORIES	ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33	09/26/2008
K000012	DIAGNOSTIC PRODUCTS CORP.	IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5	03/03/2000
K123271	MICROGENICS CORP.	ABBOTT PHENOBARBITAL ASSAY	04/26/2013
K984288	Ortho-Clinical Diagnostics, Inc.	VITROS CHEMISTRY PRODUCTS PHBR SLIDES	01/26/1999
K210858	Ortho-Clinical Diagnostics, Inc.	VITROS Chemistry Products PHBR Slides	08/13/2021
K011303	RANDOX LABORATORIES, LTD.	RANDOX PHENOBARBITAL	07/02/2001
K071644	ROCHE DIAGNOSTICS CORP.	ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620	09/12/2007
K993031	SYVA CO.	ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54	01/27/2000
K011528	SYVA CO.	EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229	06/06/2001