FDA 510(k) Application Details - K042762

Device Classification Name	Test, Time, Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K042762
Device Name	Test, Time, Partial Thromboplastin
Applicant	PENTAPHARM LTD. 1111 PENNSYLVANIA AVE., NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	M. ELISABETH BIERMAN 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	10/05/2004
Decision Date	12/22/2004
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