JMY — Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase Class I

FDA Device Classification

FDA product code JMY covers "Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase", a Class I medical device regulated under 21 CFR 862.1535. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JMY
Device Class
Class I
Regulation Number
862.1535
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No