FDA 510(k) Application Details - K961991

Device Classification Name	Instrument, Coagulation, Automated   More FDA Info for this Device
510(K) Number	K961991
Device Name	Instrument, Coagulation, Automated
Applicant	INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02173 US Other 510(k) Applications for this Company
Contact	BETTY J LANE Other 510(k) Applications for this Contact
Regulation Number	864.5400   More FDA Info for this Regulation Number
Classification Product Code	GKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/1996
Decision Date	09/04/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review