FDA 510(k) Application Details - K971464

Device Classification Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K971464
Device Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant	EURO-DIAGNOSTICA AB 155 CIDER MILL RD. RINGOES, NJ 08551 US Other 510(k) Applications for this Company
Contact	KARL A POSSELT Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	DBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1997
Decision Date	10/29/1997
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