510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CEFClass I

Electrophoretic, Protein Fractionation

21 CFR 862.1630 / Clinical Chemistry
FDA source (opens on fda.gov)

CEF is the FDA product code for Electrophoretic, Protein Fractionation, a class I device type, regulated under 21 CFR 862.1630. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CEF
Device name
Electrophoretic, Protein Fractionation
Regulation
21 CFR 862.1630
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
29
Ingested recalls
0

Clearances, product code CEF

By decision year
29 clearances under product code CEF with a decision year between 1977 and 2013, 1978 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code CEF by decision year
YearClearances
19771
19785
19801
19811
19842
19871
19892
19901
19914
19923
19931
19951
19962
19973
20131

Applicants with the most clearances

Product code CEF
Applicants holding the most 510(k) clearances under product code CEF
ApplicantClearances
Helena Laboratories, Corp.15
Electrophoresis Corp. of America5
Bio-Rad2
Beckman Instruments, Inc.1
Corning Medical & Scientific1
Immuno Assay Corp.1
Morax1
Sebia, Inc.1
Sebia1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code