FDA 510(k) Application Details - K992140

Device Classification Name	Atp And Creatine Kinase (Enzymatic), Creatine   More FDA Info for this Device
510(K) Number	K992140
Device Name	Atp And Creatine Kinase (Enzymatic), Creatine
Applicant	ABAXIS, INC. 1320 CHESAPEAKE TERRACE SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	LISA MCGRATH Other 510(k) Applications for this Contact
Regulation Number	862.1210   More FDA Info for this Regulation Number
Classification Product Code	JLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/1999
Decision Date	08/26/1999
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