FDA 510(k) Application Details - K090755

Device Classification Name	Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex   More FDA Info for this Device
510(K) Number	K090755
Device Name	Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	D. WALTER L BINDER Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	OPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2009
Decision Date	02/01/2010
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