FDA 510(k) Application Details - K990138

Device Classification Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer   More FDA Info for this Device
510(K) Number	K990138
Device Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Applicant	DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US Other 510(k) Applications for this Company
Contact	JOHN CLASS Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/1999
Decision Date	06/21/1999
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