FDA 510(k) Application Details - K973974

Device Classification Name	Enzyme Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K973974
Device Name	Enzyme Controls (Assayed And Unassayed)
Applicant	DADE INTL., INC. 2173 NW 99TH AVE. MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	BETTY HERNANDEZ-LABADIE 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	10/20/1997
Decision Date	11/06/1997
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