FDA 510(k) Application Details - K101407

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum   More FDA Info for this Device
510(K) Number	K101407
Device Name	Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Applicant	IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE NORMAN, OK 73071 US Other 510(k) Applications for this Company
Contact	SEAN K BAUMAN, PH.D Other 510(k) Applications for this Contact
Regulation Number	866.3320   More FDA Info for this Regulation Number
Classification Product Code	MIZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2010
Decision Date	07/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review