FDA 510(k) Application Details - K971777

Device Classification Name	Enzyme Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K971777
Device Name	Enzyme Controls (Assayed And Unassayed)
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	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/1997
Decision Date	05/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review