FDA 510(k) Applications for Medical Device Product Code "OEG"
(Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230)

FDA 510(k) Number Applicant Device Name Decision Date
K083615 EUROIMMUN US INC EUROIMMUN ANTI BP 180-4X ELISA (IGG) 03/16/2009
K193115 Euroimmun US, Inc. EUROIMMUN Anti-BP230-CF ELISA (IgG) 09/17/2020
K071961 MBL INTERNATIONAL CORPORATION MESACUP MODELS BP180 AND BP230 ELISA KITS 08/25/2008


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