FDA 510(k) Application Details - K052359

Device Classification Name	Radioimmunoassay, Cortisol   More FDA Info for this Device
510(K) Number	K052359
Device Name	Radioimmunoassay, Cortisol
Applicant	Lehnus & Associates Consulting 150 CHERRY LANE RD. EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	862.1205   More FDA Info for this Regulation Number
Classification Product Code	CGR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2005
Decision Date	10/03/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review