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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K013118
Device Name MODIFICATION TO ALPHA DX SYSTEM
Applicant
First Medical, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
First Medical, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number862.1215
Classification Product Code
JHX  
Subsequent Product Codes
DDR   KHO   MMI  
Date Received09/18/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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