CET
15 FDA 510(k) clearances · Product code
81 daysmedian time to decision
121 days90th percentile
15clearances measured
FDA profile
- Official device name
- Olive Oil Emulsion (Turbidimetric), Lipase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1465
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIPASE REAGENT SET (COLIPASE METHOD) (K970124) | Teco Diagnostics | 1997-03-06 |
| LIPASE REAGENT SYSTEM (K940457) | Medical Diagnostic Technologies, Inc. | 1994-06-02 |
| LIPASE REAGENT SET (K915706) | Tech Intl. Co. | 1992-02-18 |
| MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (K901858) | E.I. Dupont DE Nemours & Co., Inc. | 1990-06-12 |
| DELTATEST (R) LIPASE II (K893718) | Electro-Nucleonics, Inc. | 1989-09-28 |
| LIPASE SR LIQUID STABLE REAGENT SET (K885078) | Medical Analysis Systems, Inc. | 1989-03-13 |
| BECKMAN EPSILON(TM) LIPASE TEST KIT (K864438) | Beckman Instruments, Inc. | 1987-03-12 |
| PARAMAX LIPASE REAGENT (K862440) | American Dade | 1986-08-04 |
| ENZYGNOST LIPASE TEST (K844240) | Behring Diagnostics, Inc. | 1985-02-12 |
| NUCLIPASE (I125) PANCREATIC LIPASE (K823860) | Nuclear Diagnostics, Inc. | 1983-04-18 |
| LIPASE (K812794) | Pointe Scientific, Inc., | 1981-10-20 |
| LIPASE TEST KIT (K792289) | Mallinckrodt Critical Care | 1979-12-18 |
| HARLECO BRAND CLINICARD LIPASE TEST SET (K791922) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-27 |
| LIPASE REAGENT SET (K790796) | Alta Diagnostics, Inc. | 1979-07-17 |
| ACA LIPASE ANALYTICAL TEST PACK (K770364) | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-15 |
Track CET automatically
Every clearance here is in the API, with alerts when new ones post.