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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 K843379
Device Name VMA ASSAY KIT
Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
4 NEWLAND CRESCENT
CHARLOTTETOWN
CANADA, 
Correspondent
DIAGNOSTIC CHEMICALS, LTD. (USA)
4 NEWLAND CRESCENT
CHARLOTTETOWN
CANADA, 
Regulation Number862.1795
Classification Product Code
CDF  
Date Received08/28/1984
Decision Date 09/28/1984
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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