FDA 510(k) Application Details - K041349

Device Classification Name	Radioimmunoassay, Estradiol   More FDA Info for this Device
510(K) Number	K041349
Device Name	Radioimmunoassay, Estradiol
Applicant	IBL GMBH 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	862.1260   More FDA Info for this Regulation Number
Classification Product Code	CHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2004
Decision Date	09/24/2004
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