FDA 510(k) Application Details - K080459

Device Classification Name	Drug Specific Control Materials   More FDA Info for this Device
510(K) Number	K080459
Device Name	Drug Specific Control Materials
Applicant	CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH 1733 CANTON LANE SUITE 103 MARIETTA, GA 30062-2679 US Other 510(k) Applications for this Company
Contact	CATHY CAMBRIA Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	LAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2008
Decision Date	11/17/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review