JKF · Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
Clinical Chemistry · 21 CFR 862.1380 · Class 1
Overview
| Product Code | JKF |
|---|---|
| Device Name | Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge |
| Regulation | 21 CFR 862.1380 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | Sterling Diagnostics, Inc. | Jun 16, 1986 | SESE |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | Sterling Biochemical, Inc. | Feb 4, 1984 | SESE |
Top Applicants
- Sterling Diagnostics, Inc. — 1 clearance
- Sterling Biochemical, Inc. — 1 clearance
