FDA Product Code
FDA Product Code CHI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1465
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | Beckman Instruments, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K961179 | SENTINEL LIPASE LIQUID MODEL 17.401B | Equal Diagnostics, Inc. | 1996-07-19 | Traditional | PDF ↗ |
| K952180 | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS | Beckman Instruments, Inc. | 1995-08-17 | Traditional | PDF ↗ |
| K952647 | IL TEST LIPASE | Instrumentation Laboratory CO | 1995-07-20 | Traditional | PDF ↗ |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Dupont Medical Products | 1995-07-20 | Traditional | PDF ↗ |
| K941085 | LIPASE-PS ASSAY PROCEDURE NO. 805 | Sigma Diagnostics, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K921249 | WAKO AUTOKIT LIPASE-COLOR | Wako Chemicals USA, Inc. | 1992-07-21 | Traditional | PDF ↗ |
| K920337 | MILES LIPASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | American Research Products Co. | 1990-05-02 | Traditional | PDF ↗ |
| K897150 | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT | Toyo Jozo Co., Ltd. | 1990-02-26 | Traditional | PDF ↗ |
| K884596 | ABBOTT A-GENT LIPASE REAGENT | Abbott Laboratories | 1988-12-06 | Traditional | PDF ↗ |
| K874027 | LIPASE UV [TOYO] | Advocacy International, Ltd. | 1988-05-27 | Traditional | PDF ↗ |
| K875173 | KODAK EKTACHEM DT SLIDES (LIPA) | Eastman Kodak Company | 1988-02-24 | Traditional | PDF ↗ |
| K874640 | WAKO(TM) AUTOKIT LIPASE | Wako Chemicals USA, Inc. | 1987-12-22 | Traditional | PDF ↗ |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Nuclear Diagnostics, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K845027 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES | Eastman Kodak Company | 1985-01-18 | Traditional | PDF ↗ |
| K811553 | REAGENT SET TRIGLYCERIDES | Boehringer Mannheim Corp. | 1981-06-18 | Traditional | PDF ↗ |
| K802842 | SINGLE VIAL LIPASE TEST KIT | Biodynamics Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K760786 | ENZYMATIC LIPASE MAX-PACK REAGENT | Calbiochem | 1977-01-06 | Traditional | PDF ↗ |
Product code CHI · Class I · Clinical Chemistry. Data: openFDA.