FDA 510(k) Application Details - K953586

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K953586
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	ELIAS U.S.A., INC. 373 280TH ST. OSCEOLA, WI 54020 US Other 510(k) Applications for this Company
Contact	GOTTFRIED KELLERMAN 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	08/01/1995
Decision Date	01/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review