FDA 510(k) Applications for Medical Device Product Code "NOM"
(Antigen, Galactomannan, Aspergillus Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K093678 BIO-RAD PLATELIA ASPERGILLUS EIA MODEL 62793 01/13/2011
K060641 BIO-RAD PLATELIA ASPERGILLUS EIA, MODEL 62793 06/02/2006
K023857 BIO-RAD PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 05/16/2003


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact