FDA 510(k) Application Details - K031445

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K031445
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	MAINLINE TECHNOLOGY, INC. 3985 RESEARCH PARK DR. ANN ARBOR, MI 48108 US Other 510(k) Applications for this Company
Contact	MARTHA MAZUREK 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	05/07/2003
Decision Date	07/01/2003
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