FDA 510(k) Application Details - K050125

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K050125
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
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	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2005
Decision Date	03/18/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review