FDA 510(k) Applications for Medical Device Product Code "CJO"
(Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K982328 BAYER CORP. BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) 01/29/1999
K770155 GELMAN INSTRUMENT CO. ALKALINE PHOSPHATASE ISOYZME REAGENT SET 01/31/1977
K121907 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR 07/23/2012
K122323 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI 08/28/2012


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