FDA 510(k) Application Details - K062217

Device Classification Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)   More FDA Info for this Device
510(K) Number	K062217
Device Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Applicant	AESKU, INC 8880 NORTHWEST 18TH TERRACE MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	DAVID BELL 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	08/01/2006
Decision Date	12/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review