FDA 510(k) Application Details - K020695

Device Classification Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)   More FDA Info for this Device
510(K) Number	K020695
Device Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Applicant	CHESHIRE DIAGNOSTICS LTD. MANAGEMENT CENTRE, INWARD WAY ELLESMERE PORT CHESHIRE CH65 3EN GB Other 510(k) Applications for this Company
Contact	NEIL B STRINGER 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	03/04/2002
Decision Date	04/19/2002
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