FDA 510(k) Application Details - K092987

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K092987
Device Name	Test, Time, Prothrombin
Applicant	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	KARIN A HUGES Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	GJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2009
Decision Date	06/11/2010
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