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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Occult Blood Analyzer
510(k) Number K191147
Device Name OC-Auto SENSOR io iFOB Test
Applicant
Eiken Chemical Co., Ltd.
4-19-9, Taito
Taito-ku,  JP 110-8408
Applicant Contact Tadashi Yasuda
Correspondent
Eiken Chemical Co., Ltd.
4-19-9, Taito
Taito-ku,  JP 110-8408
Correspondent Contact Tadashi Yasuda
Regulation Number864.6550
Classification Product Code
OOX  
Date Received04/30/2019
Decision Date 01/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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