FDA 510(k) Application Details - K041687

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K041687
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT: 09VA BLDG: AP6C-2 ABBOTT PARK, IL 60064-3500 US Other 510(k) Applications for this Company
Contact	KENT SMITH 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	06/22/2004
Decision Date	08/18/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review