FDA 510(k) Application Details - K083729

Device Classification Name	Test, Time, Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K083729
Device Name	Test, Time, Partial Thromboplastin
Applicant	ANIARA DIAGNOSTICA ,LLC 6560 GOVE COURT MASON, OH 45040 US Other 510(k) Applications for this Company
Contact	OLA ANDERSON 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	12/16/2008
Decision Date	05/08/2009
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