FDA product code CEF: Electrophoretic, Protein Fractionation
CEF is the FDA product code for electrophoretic, protein fractionation. It is a Class I device, regulated under 21 CFR 862.1630 and reviewed by the Clinical Chemistry panel. FDA has cleared 29 510(k) submissions under CEF, from 9 different applicants. The average 510(k) review took 83 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic, Protein Fractionation |
| Device class | Class I |
| Regulation | 21 CFR 862.1630 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEF clearance
Top CEF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 15 | 1997-10-27 |
| Electrophoresis Corp. of America | 5 | 1978-08-10 |
| Sebia | 2 | 2013-07-26 |
| Bio-Rad | 2 | 1997-06-04 |
| Morax | 1 | 1996-07-17 |
4 more applicants have CEF clearances. See the full list in Caduvo.
Most recent CEF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130500 | Sebia | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT | 2013-07-26 | 150 |
| K972274 | Helena Laboratories | SPIFE | 1997-10-27 | 131 |
| K973316 | Helena Laboratories | REP SPE VIS-60/40 KIT | 1997-10-01 | 28 |
| K963018 | Bio-Rad | BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS | 1997-06-04 | 306 |
| K964453 | Helena Laboratories | REP 3 FLUR SPE-60 KIT | 1996-12-23 | 47 |
Recalls for CEF devices
openFDA lists no recalls for product code CEF.
Frequently asked questions
What is FDA product code CEF?
CEF is the FDA product code for electrophoretic, protein fractionation. It is a Class I device, regulated under 21 CFR 862.1630 and reviewed by the Clinical Chemistry panel.
What device class is CEF?
Class I, regulation 21 CFR 862.1630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEF?
Across 29 cleared submissions the average was 83 days from receipt to decision (median 51).
Which companies have the most CEF clearances?
Helena Laboratories (15); Electrophoresis Corp. of America (5); Sebia (2); Bio-Rad (2); Morax (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CEF
- Run a recall and safety report across every CEF manufacturer
- Watch product code CEF 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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