FDA 510(k) Application Details - K991010

Device Classification Name	Acid Phosphatase, Naphthyl Phosphate   More FDA Info for this Device
510(K) Number	K991010
Device Name	Acid Phosphatase, Naphthyl Phosphate
Applicant	ABBOTT DIAGNOSTICS MFG., INC. 1920 HURD DR. IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	LINDA MORRIS Other 510(k) Applications for this Contact
Regulation Number	862.1020   More FDA Info for this Regulation Number
Classification Product Code	CKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/1999
Decision Date	05/19/1999
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