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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic/Fluorometric Method, Catecholamines
510(k) Number K032199
Device Name ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
Applicant
Esa, Inc.
22 Alpha Rd.
Chelmsford,  MA  01824
Applicant Contact HAROLD ASP
Correspondent
Esa, Inc.
22 Alpha Rd.
Chelmsford,  MA  01824
Correspondent Contact HAROLD ASP
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received07/18/2003
Decision Date 01/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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