HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
Device Facts
| Record ID | K852867 |
|---|---|
| Device Name | HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE |
| Applicant | Hi Chem, Inc. |
| Product Code | CKA · Clinical Chemistry |
| Decision Date | Aug 29, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1030 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
