JGK — Ferric Chloride, Phenylketones (Urinary, Non-Quant.) Class I

FDA Device Classification

FDA product code JGK covers "Ferric Chloride, Phenylketones (Urinary, Non-Quant.)", a Class I medical device regulated under 21 CFR 862.1560. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JGK
Device Class
Class I
Regulation Number
862.1560
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No