CET — Olive Oil Emulsion (Turbidimetric), Lipase Class I
FDA Device Classification
Classification Details
- Product Code
- CET
- Device Class
- Class I
- Regulation Number
- 862.1465
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K970124 | teco diagnostics | LIPASE REAGENT SET (COLIPASE METHOD) | March 6, 1997 |
| K940457 | medical diagnostic technologies | LIPASE REAGENT SYSTEM | June 2, 1994 |
| K915706 | tech intl | LIPASE REAGENT SET | February 18, 1992 |
| K901858 | e.i. dupont de nemours and co | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST | June 12, 1990 |
| K893718 | electro-nucleonics | DELTATEST (R) LIPASE II | September 28, 1989 |
| K885078 | medical analysis systems | LIPASE SR LIQUID STABLE REAGENT SET | March 13, 1989 |
| K864438 | beckman instruments | BECKMAN EPSILON(TM) LIPASE TEST KIT | March 12, 1987 |
| K862440 | american dade | PARAMAX LIPASE REAGENT | August 4, 1986 |
| K844240 | behring diagnostics | ENZYGNOST LIPASE TEST | February 12, 1985 |
| K823860 | nuclear diagnostics | NUCLIPASE (I125) PANCREATIC LIPASE | April 18, 1983 |
| K812794 | pointe scientific, inc | LIPASE | October 20, 1981 |
| K792289 | mallinckrodt critical care | LIPASE TEST KIT | December 18, 1979 |
| K791922 | dade, baxter travenol diagnostics | HARLECO BRAND CLINICARD LIPASE TEST SET | November 27, 1979 |
| K790796 | alta diagnostics | LIPASE REAGENT SET | July 17, 1979 |
| K770364 | e.i. dupont de nemours and co | ACA LIPASE ANALYTICAL TEST PACK | April 15, 1977 |