FDA 510(k) Application Details - K083554

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K083554
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	CLINIQA CORPORATION 288 DISTRIBUTION STREET SAN MARCOS, CA 92078 US Other 510(k) Applications for this Company
Contact	DAWN GAST 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	12/01/2008
Decision Date	04/21/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review