FDA 510(k) Application Details - K110212

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K110212
Device Name	Test, Time, Prothrombin
Applicant	ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE 9975 Summers Ridge Road San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	MARA CALER 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	01/25/2011
Decision Date	05/01/2012
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review