Product code JKF— Clinical Chemistry
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
- Classification name
- Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
- Device class
- Class 1
- Regulation
- 21 CFR 862.1380
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code JKF
FDA has cleared devices under product code JKF between 1984 and 1986, filed by 2 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
- 1986
- 1984
Top applicants under product code JKF
Recent clearances under product code JKF
Data sourced from openFDA. This site is unofficial and independent of the FDA.