FDA 510(k) Application Details - K132174

Device Classification Name	Drug Mixture Control Materials   More FDA Info for this Device
510(K) Number	K132174
Device Name	Drug Mixture Control Materials
Applicant	TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST. HIGHLAND VILLAGE, TX 75077 US Other 510(k) Applications for this Company
Contact	STEPHANIE G GARTH Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	DIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2013
Decision Date	09/20/2013
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