CIF · Vanillin Pyruvate, Ast/Sgot
Clinical Chemistry · 21 CFR 862.1100 · Class 2
Overview
| Product Code | CIF |
|---|---|
| Device Name | Vanillin Pyruvate, Ast/Sgot |
| Regulation | 21 CFR 862.1100 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
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 the limitations in § 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 the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832790 | SERALYZER AST/SGOT REAGENT STRIPS | Miles Laboratories, Inc. | Oct 14, 1983 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 1 clearance
