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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
Predetermined Change
Control Plan Authorized		 No
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