FDA 510(k) Application Details - K092170

Device Classification Name	Test, Qualitative And Quantitative Factor Deficiency   More FDA Info for this Device
510(K) Number	K092170
Device Name	Test, Qualitative And Quantitative Factor Deficiency
Applicant	DIAGNOSTICA STAGO, INC. 5 CENTURY DR. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	UMBERTO V PARROTTA Other 510(k) Applications for this Contact
Regulation Number	864.7290   More FDA Info for this Regulation Number
Classification Product Code	GGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2009
Decision Date	12/22/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review