FDA 510(k) Application Details - K051824

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	K051824
Device Name	Drug Metabolizing Enzyme Genotyping Systems
Applicant	THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD. MADISON, WI 53719-1256 US Other 510(k) Applications for this Company
Contact	Sam Rua Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	NTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2005
Decision Date	08/18/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review