JKH · Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
Clinical Chemistry · 21 CFR 862.1420 · Class 1
Overview
| Product Code | JKH |
|---|---|
| Device Name | Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen |
| Regulation | 21 CFR 862.1420 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An isocitric dehydrogenase test system is a device intended to measure the activity of the enzyme isocitric dehydrogenase in serum and plasma. Isocitric dehydrogenase measurements are used in the diagnosis and treatment of liver disease such as viral hepatitis, cirrhosis, or acute inflammation of the biliary tract; pulmonary disease such as pulmonary infarction (local arrest or sudden insufficiency of the blood supply to the lungs), and diseases associated with pregnancy.
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 (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770902 | COLORIMETRIC DETERM. SOCITRATE DEHYDRO. | Sigma Chemical Co. | Jul 14, 1977 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
