FDA 510(k) Application Details - K043385

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K043385
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	GENZYME DIAGNOSTICS 6659 TOP GUN ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	E.V. GOORCHENKO Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2004
Decision Date	04/12/2005
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