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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 K895288
Device Name HVA EIA KIT YAMASA
Applicant
YAMASA SHOY CO., LTD.
23-8 NIHONBASHI KAKIGARACHO
1-CHOME
CHUOKU, TOKYO 103 JAPAN,  JP
Applicant Contact JIRO SAWADA
Correspondent
YAMASA SHOY CO., LTD.
23-8 NIHONBASHI KAKIGARACHO
1-CHOME
CHUOKU, TOKYO 103 JAPAN,  JP
Correspondent Contact JIRO SAWADA
Regulation Number862.1795
Classification Product Code
CDF  
Date Received08/25/1989
Decision Date 10/31/1989
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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