JMS — Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase Class I

FDA Device Classification

FDA product code JMS covers "Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase", a Class I medical device regulated under 21 CFR 862.1500. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
JMS
Device Class
Class I
Regulation Number
862.1500
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No