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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K182298
Device Name hemochroma PLUS System
Applicant
Immunostics Inc.,
38 Industrial Way E.
Suite 1
Eatontown,  NJ  07724
Applicant Contact Junghee Kim
Correspondent
Immunostics Inc.,
38 Industrial Way E.
Suite 1
Eatontown,  NJ  07724
Correspondent Contact Junghee Kim
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Code
GGM  
Date Received08/24/2018
Decision Date 11/16/2018
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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