FDA 510(k) Application Details - K984433

Device Classification Name	Biosensor, Immunoassay, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K984433
Device Name	Biosensor, Immunoassay, Cpk Or Isoenzymes
Applicant	QUANTECH LTD. 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN J HELLEN Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	MYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/1998
Decision Date	11/01/1999
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