JMK

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

Product code: JMK
Device name: Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device class: Class 1
21 CFR: 21 CFR 862.1380
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 16 (all years; only the last 3 years are listed here)

Official FDA classification page: JMK

Classification and pathway per current FDA publications. Data from openFDA (CC0).