FDA 510(k) Application Details - K970189

Device Classification Name	System, Fibrinogen Determination   More FDA Info for this Device
510(K) Number	K970189
Device Name	System, Fibrinogen Determination
Applicant	PANBIO, INC. 1539 N. IRONWOOD DR. SOUTH BEND, IN 46635 US Other 510(k) Applications for this Company
Contact	LINDA M WILLIAMS 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	01/21/1997
Decision Date	05/21/1997
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