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

Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

21 CFR 866.5110 / Immunology
FDA source (opens on fda.gov)

MLE is the FDA product code for Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control, a class II device type, regulated under 21 CFR 866.5110. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MLE
Device name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Regulation
21 CFR 866.5110
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code MLE

By decision year
3 clearances under product code MLE with a decision year between 1995 and 2001, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MLE by decision year
YearClearances
19951
19991
20011

Applicants with the most clearances

Product code MLE
Applicants holding the most 510(k) clearances under product code MLE
ApplicantClearances
Cogent Diagnotics, Ltd.1
Elias U.S.A., Inc.1
Inova Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code