FDA 510(k) Applications for Medical Device Product Code: CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)

FDA 510(k) Applications for Medical Device Product Code "CIN"
(Electrophoretic Separation, Alkaline Phosphatase Isoenzymes)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K232904	Beckman Coulter	Access Ostase	04/15/2024
K994278	BECKMAN COULTER, INC.	ACCESS OSTASE IMMUNOENZYMETRIC ASSAY	03/28/2000
K964764	BEHRING DIAGNOSTICS, INC.	OPUS BONE ALP	01/24/1997
K020625	HELENA LABORATORIES	SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346	05/06/2002
K972666	HYBRITECH, INC.	TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY	09/11/1997
K961573	HYBRITECH, INC.	TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY	08/19/1996
K200475	Immunodiagnostic Systems Ltd.	IDS-iSYS Ostase BAP	09/30/2020
K981373	METRA BIOSYSTEMS, INC.	ALKPHASE-B ASSAY KIT	05/27/1998
K043125	ORION DIAGNOSTICA OY	ORION DIAGNOSTICA UNIQ PINP RIA	05/04/2005
K011113	SEBIA	HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)	06/13/2001