FDA 510(k) Application Details - K033471

Device Classification Name	Test, Time, Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K033471
Device Name	Test, Time, Partial Thromboplastin
Applicant	R2 DIAGNOSTICS, INC. 412 SOUTH LAFAYETTE BLVD. SOUTH BEND, IN 46601 US Other 510(k) Applications for this Company
Contact	PEGGY S CARTER 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	11/03/2003
Decision Date	02/04/2004
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