CHI · Lipase-Esterase, Enzymatic, Photometric, Lipase
Clinical Chemistry · 21 CFR 862.1465 · Class 1
Overview
| Product Code | CHI |
|---|---|
| Device Name | Lipase-Esterase, Enzymatic, Photometric, 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 (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | Beckman Instruments, Inc. | Jun 4, 1997 | SESE |
| K961179 | SENTINEL LIPASE LIQUID MODEL 17.401B | Equal Diagnostics, Inc. | Jul 19, 1996 | SESE |
| K952180 | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS | Beckman Instruments, Inc. | Aug 17, 1995 | SESE |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Dupont Medical Products | Jul 20, 1995 | SESE |
| K952647 | IL TEST LIPASE | Instrumentation Laboratory CO | Jul 20, 1995 | SESE |
| K941085 | LIPASE-PS ASSAY PROCEDURE NO. 805 | Sigma Diagnostics, Inc. | May 17, 1994 | SESE |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Nuclear Diagnostics, Inc. | Feb 25, 1994 | SESE |
| K921249 | WAKO AUTOKIT LIPASE-COLOR | Wako Chemicals USA, Inc. | Jul 21, 1992 | SESE |
| K920337 | MILES LIPASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | Mar 11, 1992 | SESE |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | American Research Products Co. | May 2, 1990 | SESE |
| K897150 | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT | Toyo Jozo Co., Ltd. | Feb 26, 1990 | SESE |
| K884596 | ABBOTT A-GENT LIPASE REAGENT | Abbott Laboratories | Dec 6, 1988 | SESE |
| K874027 | LIPASE UV [TOYO] | Advocacy International, Ltd. | May 27, 1988 | SESE |
| K875173 | KODAK EKTACHEM DT SLIDES (LIPA) | Eastman Kodak Company | Feb 24, 1988 | SESE |
| K874640 | WAKO(TM) AUTOKIT LIPASE | Wako Chemicals USA, Inc. | Dec 22, 1987 | SESE |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Nuclear Diagnostics, Inc. | Sep 26, 1986 | SESE |
| K845027 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | Jan 18, 1985 | SESE |
| K811553 | REAGENT SET TRIGLYCERIDES | Boehringer Mannheim Corp. | Jun 18, 1981 | SESE |
| K802842 | SINGLE VIAL LIPASE TEST KIT | Biodynamics Corp. | Dec 18, 1980 | SESE |
| K760786 | ENZYMATIC LIPASE MAX-PACK REAGENT | Calbiochem | Jan 6, 1977 | SESE |
Top Applicants
- Wako Chemicals USA, Inc. — 2 clearances
- Nuclear Diagnostics, Inc. — 2 clearances
- Eastman Kodak Company — 2 clearances
- Beckman Instruments, Inc. — 2 clearances
- Toyo Jozo Co., Ltd. — 1 clearance
