FDA 510(k) Application Details - K980314

Device Classification Name	Test, Screening, For D Positive Fetal Rbc'S   More FDA Info for this Device
510(K) Number	K980314
Device Name	Test, Screening, For D Positive Fetal Rbc'S
Applicant	BIOPOOL INTL., INC. 1230 WILSON DR. WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	PETER L MINETTI Other 510(k) Applications for this Contact
Regulation Number	864.7455   More FDA Info for this Regulation Number
Classification Product Code	LIM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/1998
Decision Date	04/08/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review