FDA 510(k) Application Details - K000196

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K000196
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	JAN OLSEN Other 510(k) Applications for this Contact
Regulation Number	866.5680   More FDA Info for this Regulation Number
Classification Product Code	DDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2000
Decision Date	02/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review