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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
510(k) Number K952817
Device Name BIO-RAD URINARY 5-HIAA BY HPLC
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact JOHN W NELSON
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact JOHN W NELSON
Regulation Number862.1390
Classification Product Code
CDA  
Date Received06/20/1995
Decision Date 08/01/1995
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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