FDA 510(k) Application Details - K021218

Device Classification Name	Fluorometric, Cortisol   More FDA Info for this Device
510(K) Number	K021218
Device Name	Fluorometric, Cortisol
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	SHERRI L COENEN 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	04/17/2002
Decision Date	09/09/2002
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