FDA 510(k) Application Details - K030012

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K030012
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	BRENT TABER Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2003
Decision Date	01/17/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review