FDA 510(k) Application Details - K981750

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K981750
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	WIESLAB AB 1306 BAILES LN. SUITE F FREDERICK, MD 21701 US Other 510(k) Applications for this Company
Contact	WILLIAM L BOTELER JR. Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/1998
Decision Date	07/22/1998
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