FDA 510(k) Application Details - K083171

Device Classification Name	Quality Control Material, Genetics, Dna   More FDA Info for this Device
510(K) Number	K083171
Device Name	Quality Control Material, Genetics, Dna
Applicant	MAINE MOLECULAR QUALITY CONTROLS, INC. 10 SOUTHGATE ROAD SUITE 170 SCARBOROUGH, ME 04074 US Other 510(k) Applications for this Company
Contact	JOAN GORDON Other 510(k) Applications for this Contact
Regulation Number	866.5910   More FDA Info for this Regulation Number
Classification Product Code	NZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2008
Decision Date	12/16/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review