FDA 510(k) Application Details - K981824

Device Classification Name	Radioimmunoassay, Total Triiodothyronine   More FDA Info for this Device
510(K) Number	K981824
Device Name	Radioimmunoassay, Total Triiodothyronine
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	862.1710   More FDA Info for this Regulation Number
Classification Product Code	CDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/1998
Decision Date	12/22/1998
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