NBO — Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) Class II

FDA Device Classification

Classification Details

Product Code
NBO
Device Class
Class II
Regulation Number
866.5660
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K091969euroimmun usEUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)September 2, 2010
K000336rhigeneRHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 EJune 9, 2000