FDA 510(k) Application Details - K990916

Device Classification Name	Anti-Dna Indirect Immunofluorescent Solid Phase   More FDA Info for this Device
510(K) Number	K990916
Device Name	Anti-Dna Indirect Immunofluorescent Solid Phase
Applicant	STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	JOHN BREWER Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	KTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/1999
Decision Date	04/21/1999
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