FDA 510(k) Application Details - K123612

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K123612
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	FUJIREBIO DIAGNOSTICS, INC. 940 CROSSROADS BLVD. SEGUIN, TX 78155 US Other 510(k) Applications for this Company
Contact	KENT PRUETT Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2012
Decision Date	01/17/2013
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