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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 -1803
Applicant Contact FRANK MATARRESE
Correspondent
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
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
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