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

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

OEG is the FDA product code for Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "The device is intended as an aid in the diagnosis of bullous pemphigoid". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OEG
Device name
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
FDA definition
The device is intended as an aid in the diagnosis of bullous pemphigoid.
Regulation
21 CFR 866.5660
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 OEG

By decision year
3 clearances under product code OEG with a decision year between 2008 and 2020, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OEG by decision year
YearClearances
20081
20091
20201

Applicants with the most clearances

Product code OEG
Applicants holding the most 510(k) clearances under product code OEG
ApplicantClearances
Euroimmun US Inc.2
Mbl International Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code