FDA 510(k) Application Details - K072257

Device Classification Name	Drug Specific Control Materials   More FDA Info for this Device
510(K) Number	K072257
Device Name	Drug Specific Control Materials
Applicant	MORE DIAGNOSTICS 2020 11TH ST. LOS OSOS, CA 93402 US Other 510(k) Applications for this Company
Contact	JAMES W SNIPES Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	LAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2007
Decision Date	01/30/2008
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