FDA 510(k) Application Details - K131479

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K131479
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US Other 510(k) Applications for this Company
Contact	JUSTIN PADIA 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	05/22/2013
Decision Date	10/07/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review