FDA 510(k) Application Details - K990258

Device Classification Name	Test,Immunoassay,Biosensor,Hcg   More FDA Info for this Device
510(K) Number	K990258
Device Name	Test,Immunoassay,Biosensor,Hcg
Applicant	QUANTECH LTD. 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN HELLEN Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	NAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/1999
Decision Date	12/21/1999
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