CET · Olive Oil Emulsion (Turbidimetric), Lipase
Clinical Chemistry · 21 CFR 862.1465 · Class 1
Overview
| Product Code | CET |
|---|---|
| Device Name | Olive Oil Emulsion (Turbidimetric), 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.
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970124 | LIPASE REAGENT SET (COLIPASE METHOD) | Teco Diagnostics | Mar 6, 1997 | SESE |
| K940457 | LIPASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | Jun 2, 1994 | SESE |
| K915706 | LIPASE REAGENT SET | Tech Intl. Co. | Feb 18, 1992 | SESE |
| K901858 | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST | E.I. Dupont DE Nemours & Co., Inc. | Jun 12, 1990 | SESE |
| K893718 | DELTATEST (R) LIPASE II | Electro-Nucleonics, Inc. | Sep 28, 1989 | SESE |
| K885078 | LIPASE SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | Mar 13, 1989 | SESE |
| K864438 | BECKMAN EPSILON(TM) LIPASE TEST KIT | Beckman Instruments, Inc. | Mar 12, 1987 | SESE |
| K862440 | PARAMAX LIPASE REAGENT | American Dade | Aug 4, 1986 | SESE |
| K844240 | ENZYGNOST LIPASE TEST | Behring Diagnostics, Inc. | Feb 12, 1985 | SESE |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Nuclear Diagnostics, Inc. | Apr 18, 1983 | SESE |
| K812794 | LIPASE | Pointe Scientific, Inc., | Oct 20, 1981 | SESE |
| K792289 | LIPASE TEST KIT | Mallinckrodt Critical Care | Dec 18, 1979 | SESE |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Dade, Baxter Travenol Diagnostics, Inc. | Nov 27, 1979 | SESE |
| K790796 | LIPASE REAGENT SET | Alta Diagnostics, Inc. | Jul 17, 1979 | SESE |
| K770364 | ACA LIPASE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Apr 15, 1977 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
- Teco Diagnostics — 1 clearance
- Tech Intl. Co. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance
- Nuclear Diagnostics, Inc. — 1 clearance
