FDA 510(k) Application Details - K994278

Device Classification Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   More FDA Info for this Device
510(K) Number	K994278
Device Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant	BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 SAN DIEGO, CA 92196 US Other 510(k) Applications for this Company
Contact	JILL KULL Other 510(k) Applications for this Contact
Regulation Number	862.1050   More FDA Info for this Regulation Number
Classification Product Code	CIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/1999
Decision Date	03/28/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review