FDA 510(k) Application Details - K982121

Device Classification Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K982121
Device Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston Other 510(k) Applications for this Contact
Regulation Number	866.5090   More FDA Info for this Regulation Number
Classification Product Code	DBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/1998
Decision Date	09/17/1998
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