FDA 510(k) Application Details - K970645

Device Classification Name	Test, Thrombin Time   More FDA Info for this Device
510(K) Number	K970645
Device Name	Test, Thrombin Time
Applicant	BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 SAN JOSE, CA 95161-9013 US Other 510(k) Applications for this Company
Contact	PAUL L ROGERS, JR. Other 510(k) Applications for this Contact
Regulation Number	864.7875   More FDA Info for this Regulation Number
Classification Product Code	GJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/1997
Decision Date	05/19/1997
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