FDA 510(k) Application Details - K052932

Device Classification Name	Cryptosporidium Spp.   More FDA Info for this Device
510(K) Number	K052932
Device Name	Cryptosporidium Spp.
Applicant	TECHLAB, INC. 2001 KRAFT DR. BLACKSBURG, VA 24060-6358 US Other 510(k) Applications for this Company
Contact	DAVID M LYERLY Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	MHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2005
Decision Date	11/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review