FDA 510(k) Application Details - K022757

Device Classification Name	Colorimetric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K022757
Device Name	Colorimetric Method, Cpk Or Isoenzymes
Applicant	HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 BEAUMONT, TX 77704 US Other 510(k) Applications for this Company
Contact	PATRICIA FRANKS Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2002
Decision Date	10/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review