SINGLE VIAL LACTATE
Device Facts
| Record ID | K780563 |
|---|---|
| Device Name | SINGLE VIAL LACTATE |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | CFJ · Clinical Chemistry |
| Decision Date | Apr 18, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1440 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
