FDA 510(k) Application Details - K112422

Device Classification Name	Antisera, Latex Agglutination, Cryptococcus Neoformans   More FDA Info for this Device
510(K) Number	K112422
Device Name	Antisera, Latex Agglutination, Cryptococcus Neoformans
Applicant	IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE NORMAN, OK 73071 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	GMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2011
Decision Date	03/28/2012
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