FDA 510(k) Application Details - K042919

Device Classification Name	Test, Fibrinogen   More FDA Info for this Device
510(K) Number	K042919
Device Name	Test, Fibrinogen
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	864.7340   More FDA Info for this Regulation Number
Classification Product Code	GIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2004
Decision Date	11/29/2004
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