FDA 510(k) Application Details - K992858

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K992858
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	ABBOTT LABORATORIES DEPT 9YC, BIDG. AP31 200 ABBOTT PARK ROAD ABBOTT PARK, IL 60064-6200 US Other 510(k) Applications for this Company
Contact	MARGARET PROCHNIAK Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/1999
Decision Date	10/25/1999
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