FDA 510(k) Application Details - K971858

Device Classification Name	System, Fibrinogen Determination   More FDA Info for this Device
510(K) Number	K971858
Device Name	System, Fibrinogen Determination
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST.LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAM R GILBERT Other 510(k) Applications for this Contact
Regulation Number	864.7340   More FDA Info for this Regulation Number
Classification Product Code	KQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1997
Decision Date	10/09/1997
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