FDA 510(k) Application Details - K013076

Device Classification Name	Radioimmunoassay, Vancomycin   More FDA Info for this Device
510(K) Number	K013076
Device Name	Radioimmunoassay, Vancomycin
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	MARY BETH TANG Other 510(k) Applications for this Contact
Regulation Number	862.3950   More FDA Info for this Regulation Number
Classification Product Code	LEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2001
Decision Date	12/12/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review