DeviceClearance

Product code JMK— Clinical Chemistry

ULTRAZYME PLUS HBD

Classification name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device class
Class 1
Regulation
21 CFR 862.1380
Advisory panel
Clinical Chemistry
Total cleared
16
First cleared
Most recent

Market context for product code JMK

FDA has cleared 16 devices under product code JMK between 1976 and 1999, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code JMK

Recent clearances under product code JMK

Data sourced from openFDA. This site is unofficial and independent of the FDA.