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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
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