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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
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