FDA 510(k) Application Details - K973832

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K973832
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	Ruth Forstadt Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/1997
Decision Date	10/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review