FDA 510(k) Application Details - K984400

Device Classification Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K984400
Device Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	BIO-RAD 9500 JERONIMO RD. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	ELIZABETH PLATT Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	DHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/1998
Decision Date	12/18/1998
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