FDA 510(k) Application Details - K061377

Device Classification Name	Apolipoproteins   More FDA Info for this Device
510(K) Number	K061377
Device Name	Apolipoproteins
Applicant	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US Other 510(k) Applications for this Company
Contact	WILLIAM WALTERS Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MSJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2006
Decision Date	03/28/2007
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