FDA 510(k) Application Details - K120001

Device Classification Name	Giardia Spp.   More FDA Info for this Device
510(K) Number	K120001
Device Name	Giardia Spp.
Applicant	TRINITY BIOTECH 5919 FARNSWORTH CT. CALIFORNIA, CA 92008 US Other 510(k) Applications for this Company
Contact	LUPE KAGAN Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	MHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2012
Decision Date	03/01/2013
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