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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 K931148
Device Name MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM
Applicant
Esa, Inc.
45 Wiggins Ave.
Bedford,  MA  01730
Applicant Contact PRENTISS C HIGGINS
Correspondent
Esa, Inc.
45 Wiggins Ave.
Bedford,  MA  01730
Correspondent Contact PRENTISS C HIGGINS
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received03/05/1993
Decision Date 06/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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