FDA 510(k) Application Details - K033731

Device Classification Name	Fluorometric, Cortisol   More FDA Info for this Device
510(K) Number	K033731
Device Name	Fluorometric, Cortisol
Applicant	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	KIMBERLY PETERSON Other 510(k) Applications for this Contact
Regulation Number	862.1205   More FDA Info for this Regulation Number
Classification Product Code	JFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2003
Decision Date	02/20/2004
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