FDA 510(k) Application Details - K993839

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K993839
Device Name	Extractable Antinuclear Antibody, Antigen And Control
Applicant	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14702 US Other 510(k) Applications for this Company
Contact	WAYNE KVETKOSKY 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	11/12/1999
Decision Date	01/12/2000
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