FDA 510(k) Application Details - K974370

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K974370
Device Name	System, Test, Rheumatoid Factor
Applicant	STANBIO LABORATORY 2930 EAST HOUSTON ST. SAN ANTONIO, TX 78202 US Other 510(k) Applications for this Company
Contact	KIRK JOHNSON Other 510(k) Applications for this Contact
Regulation Number	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/1997
Decision Date	02/17/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review