FDA 510(k) Application Details - K120946

Device Classification Name	Antigen, Elisa, Cryptococcus   More FDA Info for this Device
510(K) Number	K120946
Device Name	Antigen, Elisa, Cryptococcus
Applicant	IMMUNO-MYCOLOGICS, INC. 116 S Crawford Ave Norman, OK 73069 US Other 510(k) Applications for this Company
Contact	SEAN K BAUMAN Other 510(k) Applications for this Contact
Regulation Number	866.3165   More FDA Info for this Regulation Number
Classification Product Code	MDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2012
Decision Date	12/17/2012
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