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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K014024
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
MMI  
Subsequent Product Codes
GKF   JHX   KHO  
Date Received12/06/2001
Decision Date 12/18/2001
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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