FDA 510(k) Application Details - K070810

Device Classification Name	Fluorescence Polarization Immunoassay, Theophylline   More FDA Info for this Device
510(K) Number	K070810
Device Name	Fluorescence Polarization Immunoassay, Theophylline
Applicant	BIOKIT S.A. CAN MALE S/N LLISSA D'AMUNT BARCELONA 08186 ES Other 510(k) Applications for this Company
Contact	JOAN GUIXER Other 510(k) Applications for this Contact
Regulation Number	862.3880   More FDA Info for this Regulation Number
Classification Product Code	LGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2007
Decision Date	06/08/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review