FDA 510(k) Application Details - K973973

Device Classification Name	Digoxin Control Serum, Ria   More FDA Info for this Device
510(K) Number	K973973
Device Name	Digoxin Control Serum, Ria
Applicant	BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	JODY J SAVAGE Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	DMP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/1997
Decision Date	11/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review