FDA 510(k) Application Details - K982471

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K982471
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	JULIE A SMITH 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	07/16/1998
Decision Date	08/06/1998
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