JLK — Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity Class I

FDA Device Classification

FDA product code JLK covers "Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity", a Class I medical device regulated under 21 CFR 862.1320. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JLK
Device Class
Class I
Regulation Number
862.1320
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No