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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 K791837
Device Name VMA BY COLUMN TEST
Applicant
BIO-RAD
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIO-RAD
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1795
Classification Product Code
CDF  
Date Received09/14/1979
Decision Date 10/30/1979
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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