FDA 510(k) Application Details - K102700

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K102700
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN 9975 Summers Ridge Road San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	EDWARD BREHM 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	09/20/2010
Decision Date	12/21/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review