CJK — Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes Class II

FDA Device Classification

FDA product code CJK covers "Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1050. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
CJK
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
K880344bd becton dickinson vacutainer systems preanalyticIQ ALKALINE PHOSPHATASEMarch 1, 1988