CFG · Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Clinical Chemistry · 21 CFR 862.1465 · Class 1
Overview
| Product Code | CFG |
|---|---|
| Device Name | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase |
| Regulation | 21 CFR 862.1465 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Classification Rationale
Class I (general 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K860554 | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) | Sterling Diagnostics, Inc. | Mar 14, 1986 | SESE |
| K800550 | LIPASE DETERMINATION | The Dow Chemical Co. | Apr 2, 1980 | SESE |
Top Applicants
- Sterling Diagnostics, Inc. — 1 clearance
- The Dow Chemical Co. — 1 clearance
