FDA 510(k) Application Details - K972666

Device Classification Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   More FDA Info for this Device
510(K) Number	K972666
Device Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant	HYBRITECH, INC. 9850 DISTRIBUTION AVE. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Gregory P Payne 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	07/16/1997
Decision Date	09/11/1997
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