FDA 510(k) Application Details - K000489

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K000489
Device Name	Extractable Antinuclear Antibody, Antigen And Control
Applicant	HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. WEST SACRAMENTO, CA 95691-6221 US Other 510(k) Applications for this Company
Contact	VIRGINIA CAPPEL Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2000
Decision Date	04/05/2000
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