FDA 510(k) Application Details - K113046

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K113046
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	AMEDITECH, INC. 10340 CAMINO SANTA FE SUITE F SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Greg Cerra Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2011
Decision Date	11/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review