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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
510(k) Number K873372
Device Name HVA & HOMOVANILLIC ACID BY HPLC METHOD
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact FRANK MATARRESE
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact FRANK MATARRESE
Regulation Number862.1795
Classification Product Code
CDF  
Date Received08/24/1987
Decision Date 12/22/1987
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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