CER · 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
Clinical Chemistry · 21 CFR 862.1440 · Class 2
Overview
| Product Code | CER |
|---|---|
| Device Name | 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase |
| Regulation | 21 CFR 862.1440 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K792416 | ELVI TOTAL PROTEINS | Volu Sol Medical Industries | Dec 7, 1979 | SESE |
Top Applicants
- Volu Sol Medical Industries — 1 clearance
