CIO — Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
CIO
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
K880177tech-coALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATApril 5, 1988
K860351sterling diagnosticsALKALINE PHOSPHATASE REAGENT SETFebruary 11, 1986
K855192technostics intlALKALINE PHOSPHATASE REAGENT SETJanuary 14, 1986
K844498sandare chemical coSANDARE ALKALINE PHOSPHATASE PROCEDUREDecember 10, 1984
K844237livonia diagnosticsALKALINE PHOSPHATASE REAGENT SETNovember 20, 1984
K841064medical specialtiesALKALINE PHOSPHOTASE REAGENT SETMay 1, 1984
K823578hoffmann-la rocheCOBAS STANDARDS FOR CALCIUM-IN-ORGANICJanuary 7, 1983
K821200omega medical electronicsALKALINE PHOSPHOTASE REAGENT SETJuly 13, 1982
K781324analytical and research chemicalsALP TESTAugust 31, 1978
K772257stanbio laboratoryALKALINE PHOSPHATASE TEST SETDecember 22, 1977
K770453icn pharmaceuticalsPHOSPHATASE PROCEDURE, TEKPOINT ALKALINEMay 3, 1977