FDA 510(k) Application Details - K001603

Device Classification Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   More FDA Info for this Device
510(K) Number	K001603
Device Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant	REPROMEDIX CORP. 86 CUMMINGS PARK, WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	HAN-SOO KIM Other 510(k) Applications for this Contact
Regulation Number	862.1700   More FDA Info for this Regulation Number
Classification Product Code	KLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2000
Decision Date	10/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review