FDA 510(k) Application Details - K981263

Device Classification Name	Antigens, Iha, Toxoplasma Gondii   More FDA Info for this Device
510(K) Number	K981263
Device Name	Antigens, Iha, Toxoplasma Gondii
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	CAROL MARBLE Other 510(k) Applications for this Contact
Regulation Number	866.3780   More FDA Info for this Regulation Number
Classification Product Code	GMM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1998
Decision Date	08/06/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review