CIQ · Diazo, Ast/Sgot
Clinical Chemistry · 21 CFR 862.1100 · Class 2
Overview
| Product Code | CIQ |
|---|---|
| Device Name | Diazo, 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | Jun 7, 1988 | SESE |
| K860216 | SGOT (AST) REAGENT SET | Sterling Diagnostics, Inc. | Apr 3, 1986 | SESE |
| K855189 | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| K844322 | SGOT REAGENT SET | Livonia Diagnostics, Inc. | Nov 27, 1984 | SESE |
| K841065 | SGOT REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K821209 | SGOT REAGENT SET | Omega Medical Electronics | Jul 14, 1982 | SESE |
| K820466 | SGOT REAGENT SET | Anco Medical Reagents & Assoc. | Mar 11, 1982 | SESE |
Top Applicants
- Anco Medical Reagents & Assoc. — 1 clearance
- Livonia Diagnostics, Inc. — 1 clearance
- Medical Specialties, Inc. — 1 clearance
- Omega Medical Electronics — 1 clearance
- Sterling Diagnostics, Inc. — 1 clearance
