FDA 510(k) Application Details - K992710

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K992710
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	ABBOTT LABORATORIES DEPT 9YC, BIDG. AP31 200 ABBOTT PARK ROAD ABBOTT PARK, IL 60064-6200 US Other 510(k) Applications for this Company
Contact	KATHERINE M WORTLEY 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	08/11/1999
Decision Date	11/24/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review