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MDU — Antigen, Elisa, Cryptococcus Class II

FDA Device Classification

Classification Details

Product Code
MDU
Device Class
Class II
Regulation Number
866.3165
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K120946immuno-mycologicsALPHA CRYPTOCOCCAL ANTIGEN EIADecember 17, 2012
K904393meridian diagnosticsPREMIER-CRYPTOCOCCAL ANTIGENJanuary 25, 1991