FDA 510(k) Application Details - K090105

Device Classification Name	Test, Time, Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K090105
Device Name	Test, Time, Partial Thromboplastin
Applicant	R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. SOUTH BEND, IN 46628 US Other 510(k) Applications for this Company
Contact	MARC D GOLDFORD Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2009
Decision Date	12/30/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review