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

Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)

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

NBO is the FDA product code for Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3), a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NBO
Device name
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
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
2
Ingested recalls
0

Clearances, product code NBO

By decision year
2 clearances under product code NBO with a decision year between 2000 and 2010, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NBO by decision year
YearClearances
20001
20101

Applicants with the most clearances

Product code NBO
Applicants holding the most 510(k) clearances under product code NBO
ApplicantClearances
Euroimmun US Inc.1
Rhigene, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code