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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 K963938
Device Name MODEL 5500 CEAS
Applicant
Esa, Inc.
22 Alpha Rd.
Chelmsford,  MA  01824
Applicant Contact JAMES MAYOL
Correspondent
Esa, Inc.
22 Alpha Rd.
Chelmsford,  MA  01824
Correspondent Contact JAMES MAYOL
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received10/01/1996
Decision Date 12/26/1996
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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