FDA Product Code
FDA Product Code CET — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1465
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970124 | LIPASE REAGENT SET (COLIPASE METHOD) | Teco Diagnostics | 1997-03-06 | Traditional | PDF ↗ |
| K940457 | LIPASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K915706 | LIPASE REAGENT SET | Tech Intl. Co. | 1992-02-18 | Traditional | PDF ↗ |
| K901858 | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST | E.I. Dupont DE Nemours & Co., Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K893718 | DELTATEST (R) LIPASE II | Electro-Nucleonics, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K885078 | LIPASE SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1989-03-13 | Traditional | PDF ↗ |
| K864438 | BECKMAN EPSILON(TM) LIPASE TEST KIT | Beckman Instruments, Inc. | 1987-03-12 | Traditional | PDF ↗ |
| K862440 | PARAMAX LIPASE REAGENT | American Dade | 1986-08-04 | Traditional | PDF ↗ |
| K844240 | ENZYGNOST LIPASE TEST | Behring Diagnostics, Inc. | 1985-02-12 | Traditional | PDF ↗ |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Nuclear Diagnostics, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K812794 | LIPASE | Pointe Scientific, Inc., | 1981-10-20 | Traditional | PDF ↗ |
| K792289 | LIPASE TEST KIT | Mallinckrodt Critical Care | 1979-12-18 | Traditional | PDF ↗ |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K790796 | LIPASE REAGENT SET | Alta Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K770364 | ACA LIPASE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-15 | Traditional | PDF ↗ |
Product code CET · Class I · Clinical Chemistry. Data: openFDA.