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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 K894966
Device Name PLASMA CATECHOLAMINES BY HPLC
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact LYNN C SHANTA
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact LYNN C SHANTA
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received08/07/1989
Decision Date 10/25/1989
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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