Product code JKH— Clinical Chemistry
COLORIMETRIC DETERM. SOCITRATE DEHYDRO.
- Classification name
- Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
- Device class
- Class 1
- Regulation
- 21 CFR 862.1420
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code JKH
FDA has cleared device under product code JKH, all in 1977, filed by 1 applicant company. 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.
Top applicants under product code JKH
Recent clearances under product code JKH
Data sourced from openFDA. This site is unofficial and independent of the FDA.