FDA 510(k) Application Details - K042080

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K042080
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. FORT LAUDERDALE, FL 33309 US Other 510(k) Applications for this Company
Contact	KAREN DEVINCENT 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	08/03/2004
Decision Date	08/19/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review