CJO — Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
CJO
Device Class
Class II
Regulation Number
862.1050
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122323siemens healthcare diagnosticsDIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISAugust 28, 2012
K121907siemens healthcare diagnosticsDIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHJuly 23, 2012
K982328bayerBAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)January 29, 1999
K770155gelman instrumentALKALINE PHOSPHATASE ISOYZME REAGENT SETJanuary 31, 1977