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MIZ — Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum Class II

FDA Device Classification

Classification Details

Product Code
MIZ
Device Class
Class II
Regulation Number
866.3320
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K101407immuno-mycologicsALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102July 19, 2011
K915700meridian diagnosticsPERMIER HISTOPLASMAJuly 30, 1992