FDA product code CET: Olive Oil Emulsion (Turbidimetric), Lipase
CET is the FDA product code for olive oil emulsion (turbidimetric), lipase. It is a Class I device, regulated under 21 CFR 862.1465 and reviewed by the Clinical Chemistry panel. FDA has cleared 15 510(k) submissions under CET, from 14 different applicants. The average 510(k) review took 77 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Olive Oil Emulsion (Turbidimetric), Lipase |
| Device class | Class I |
| Regulation | 21 CFR 862.1465 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CET clearance
Top CET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1990-06-12 |
| Teco Diagnostics | 1 | 1997-03-06 |
| Medical Diagnostic Technologies, Inc. | 1 | 1994-06-02 |
| Tech Intl. Co. | 1 | 1992-02-18 |
| Electro-Nucleonics, Inc. | 1 | 1989-09-28 |
9 more applicants have CET clearances. See the full list in Caduvo.
Most recent CET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970124 | Teco Diagnostics | LIPASE REAGENT SET (COLIPASE METHOD) | 1997-03-06 | 51 |
| K940457 | Medical Diagnostic Technologies, Inc. | LIPASE REAGENT SYSTEM | 1994-06-02 | 121 |
| K915706 | Tech Intl. Co. | LIPASE REAGENT SET | 1992-02-18 | 81 |
| K901858 | E.I. Dupont DE Nemours & Co., Inc. | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST | 1990-06-12 | 49 |
| K893718 | Electro-Nucleonics, Inc. | DELTATEST (R) LIPASE II | 1989-09-28 | 134 |
Recalls for CET devices
openFDA lists no recalls for product code CET.
Frequently asked questions
What is FDA product code CET?
CET is the FDA product code for olive oil emulsion (turbidimetric), lipase. It is a Class I device, regulated under 21 CFR 862.1465 and reviewed by the Clinical Chemistry panel.
What device class is CET?
Class I, regulation 21 CFR 862.1465. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CET?
Across 15 cleared submissions the average was 77 days from receipt to decision (median 81).
Which companies have the most CET clearances?
E.I. Dupont DE Nemours & Co., Inc. (2); Teco Diagnostics (1); Medical Diagnostic Technologies, Inc. (1); Tech Intl. Co. (1); Electro-Nucleonics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CET
- Run a recall and safety report across every CET manufacturer
- Watch product code CET for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times