FDA 510(k) Application Details - K013118

Device Classification Name	Fluorometric Method, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K013118
Device Name	Fluorometric Method, Cpk Or Isoenzymes
Applicant	FIRST MEDICAL, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	09/18/2001
Decision Date	10/15/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review