FDA 510(k) Application Details - K030397

Device Classification Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)   More FDA Info for this Device
510(K) Number	K030397
Device Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Applicant	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH EH26 OPL GB Other 510(k) Applications for this Company
Contact	DANIELLE M KNIGHT Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MSV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2003
Decision Date	03/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review