FDA 510(k) Application Details - K981373

Device Classification Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   More FDA Info for this Device
510(K) Number	K981373
Device Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant	METRA BIOSYSTEMS, INC. 265 NORTH WHISMAN RD. MOUNTAIN VIEW, CA 94043-3911 US Other 510(k) Applications for this Company
Contact	JILL VISOR 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	04/16/1998
Decision Date	05/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review