JNJ — Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase Class I

FDA Device Classification

FDA product code JNJ covers "Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase", a Class I medical device regulated under 21 CFR 862.1650. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JNJ
Device Class
Class I
Regulation Number
862.1650
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No