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

Electrophoretic, Lactate Dehydrogenase Isoenzymes

21 CFR 862.1445 / Clinical Chemistry
FDA source (opens on fda.gov)

CFE is the FDA product code for Electrophoretic, Lactate Dehydrogenase Isoenzymes, a class II device type, regulated under 21 CFR 862.1445. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CFE
Device name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
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
28
Ingested recalls
0

Clearances, product code CFE

By decision year
28 clearances under product code CFE with a decision year between 1978 and 2010, 1979 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code CFE by decision year
YearClearances
19782
19795
19802
19832
19842
19851
19861
19874
19892
19911
19921
19941
19971
20022
20101

Applicants with the most clearances

Product code CFE
Applicants holding the most 510(k) clearances under product code CFE
ApplicantClearances
Helena Laboratories, Corp.11
Corning Medical & Scientific3
Electrophoresis Corp. of America3
E.I. Dupont de Nemours & Co., Inc.2
Beckman Instruments, Inc.1
Clinical Sciences, Inc.1
Electrophoresis Corp.1
Em Industries, Inc.1
Hoffmann-La Roche, Inc.1
Roche Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code