FDA product code CFE: Electrophoretic, Lactate Dehydrogenase Isoenzymes
CFE is the FDA product code for electrophoretic, lactate dehydrogenase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1445 and reviewed by the Clinical Chemistry panel. FDA has cleared 28 510(k) submissions under CFE, from 12 different applicants. The average 510(k) review took 58 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1445 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFE clearance
Top CFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 11 | 2002-10-01 |
| Corning Medical & Scientific | 3 | 1984-05-16 |
| Electrophoresis Corp. of America | 3 | 1979-09-17 |
| Sebia | 2 | 2010-08-31 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1992-04-29 |
7 more applicants have CFE clearances. See the full list in Caduvo.
Most recent CFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100307 | Sebia | GELSCAN, MODEL 1206 | 2010-08-31 | 209 |
| K022455 | Helena Laboratories | SPIFE LD-12 KIT, MODEL 3338 | 2002-10-01 | 67 |
| K020467 | Helena Laboratories | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | 2002-03-29 | 45 |
| K970477 | Sebia | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT | 1997-03-10 | 31 |
| K940224 | Helena Laboratories | CARDIO REP LD | 1994-08-17 | 211 |
Recalls for CFE devices
openFDA lists no recalls for product code CFE.
Frequently asked questions
What is FDA product code CFE?
CFE is the FDA product code for electrophoretic, lactate dehydrogenase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1445 and reviewed by the Clinical Chemistry panel.
What device class is CFE?
Class II, regulation 21 CFR 862.1445. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFE?
Across 28 cleared submissions the average was 58 days from receipt to decision (median 42).
Which companies have the most CFE clearances?
Helena Laboratories (11); Corning Medical & Scientific (3); Electrophoresis Corp. of America (3); Sebia (2); E.I. Dupont DE Nemours & Co., Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code CFE
- Run a recall and safety report across every CFE manufacturer
- Watch product code CFE 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.
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