Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
This device is a colorimetric clinical chemistry reagent system using the dinitrophenyl hydrazone reaction to measure hydroxybutyric dehydrogenase (HBD) activity in patient specimens, an enzyme associated with myocardial and hepatic injury when elevated in serum. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket notification. The product code is JKF, regulated under 21 CFR 862.1380, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JKF
- Device Class
- FDA class 1
- Regulation Number
- 862.1380
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.