FDA 510(k) Application Details - K012164

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K012164
Device Name	Enzyme Immunoassay, Methadone
Applicant	AMERICAN BIO MEDICA CORP. 9110 RED BRANCH RD. COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	HENRY WELLS Other 510(k) Applications for this Contact
Regulation Number	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2001
Decision Date	11/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review