FDA 510(k) Application Details - K982298

Device Classification Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   More FDA Info for this Device
510(K) Number	K982298
Device Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant	BIOTECX LABORATORIES, INC. 6023 SOUTH LOOP EAST HOUSTON, TX 77033 US Other 510(k) Applications for this Company
Contact	MOHAN MEHRA 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	07/01/1998
Decision Date	02/03/1999
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