FDA 510(k) Application Details - K040296

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K040296
Device Name	Test, Time, Prothrombin
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	864.7750   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	02/09/2004
Decision Date	05/24/2004
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