FDA 510(k) Application Details - K011813

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K011813
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	AMEDITECH, INC. 10340 CAMINO SANTA FE SUITES F-G SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN WU Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2001
Decision Date	10/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review