Product code CHI
- Device name
- Lipase-Esterase, Enzymatic, Photometric, Lipase
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1465
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | Beckman Instruments, Inc. | 1997-06-04 |
| K961179 | SENTINEL LIPASE LIQUID MODEL 17.401B | Equal Diagnostics, Inc. | 1996-07-19 |
| K952180 | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS | Beckman Instruments, Inc. | 1995-08-17 |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Dupont Medical Products | 1995-07-20 |
| K952647 | IL TEST LIPASE | Instrumentation Laboratory CO | 1995-07-20 |
| K941085 | LIPASE-PS ASSAY PROCEDURE NO. 805 | Sigma Diagnostics, Inc. | 1994-05-17 |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1994-02-25 |
| K921249 | WAKO AUTOKIT LIPASE-COLOR | Wako Chemicals USA, Inc. | 1992-07-21 |
| K920337 | MILES LIPASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-11 |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | American Research Products Co. | 1990-05-02 |
| K897150 | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT | Toyo Jozo Co., Ltd. | 1990-02-26 |
| K884596 | ABBOTT A-GENT LIPASE REAGENT | Abbott Laboratories | 1988-12-06 |
| K874027 | LIPASE UV [TOYO] | Advocacy International, Ltd. | 1988-05-27 |
| K875173 | KODAK EKTACHEM DT SLIDES (LIPA) | Eastman Kodak Company | 1988-02-24 |
| K874640 | WAKO(TM) AUTOKIT LIPASE | Wako Chemicals USA, Inc. | 1987-12-22 |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Nuclear Diagnostics, Inc. | 1986-09-26 |
| K845027 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1985-01-18 |
| K811553 | REAGENT SET TRIGLYCERIDES | Boehringer Mannheim Corp. | 1981-06-18 |
| K802842 | SINGLE VIAL LIPASE TEST KIT | Biodynamics Corp. | 1980-12-18 |
| K760786 | ENZYMATIC LIPASE MAX-PACK REAGENT | Calbiochem | 1977-01-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740180713 | Alinity | ABBOTT IRELAND | 2025-10-24 |
| 00380740180720 | ARCHITECT | ABBOTT IRELAND | 2025-10-24 |
| 00380740204020 | ARCHITECT | ABBOTT IRELAND | 2025-10-24 |
| 00380740204037 | Alinity | ABBOTT IRELAND | 2025-10-24 |
| 06971674866978 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866961 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866954 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866947 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866930 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866916 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674866923 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 05055273204247 | LIPASE (LPS) | RANDOX LABORATORIES LIMITED | 2022-10-04 |
| 00817302024135 | CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024616 | CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024470 | CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT DT621 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024357 | CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT CC621 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00630414292748 | Dimension Lipase (LIP) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2021-11-11 |
| 00630414306247 | Dimension Lipase (LIP) Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2021-11-11 |
| 00630414292762 | Dimenison Vista Lipase Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2021-11-05 |
| 00630414306254 | Dimenison Vista Lipase Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | 2021-11-05 |
| 04015630926985 | Lipase colorimetric assay | Roche Diagnostics GmbH | 2021-02-08 |
| 04015630917570 | Lipase colorimetric assay | Roche Diagnostics GmbH | 2021-01-18 |
| 04015630934812 | Lipase colorimetric | Roche Diagnostics GmbH | 2021-01-18 |
| 00630414596358 | Atellica CH Lip | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768020223 | Dimension Vista® Flex® reagent cartridge LIPL | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768025532 | Dimension® Flex® reagent cartridge LIPL | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414482446 | ADVIA® Chemistry LIP Lipase Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 08058056680617 | Lipase Color Liquid | SENTINEL CH. SPA | 2017-01-16 |
| 03610230004944 | ABX PENTRA LIPASE CP | HORIBA ABX SAS | 2016-08-23 |
| 08058056681782 | Lipase NG | SENTINEL CH. SPA | 2016-08-07 |