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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 K163465
Device Name hemochroma PLUS System
Applicant
Immunostics Inc.,
1750 Brielle Ave. A5
Ocean,  NJ  07712
Applicant Contact ANTOINETTE PRUSIK
Correspondent
Immunostics Inc.,
1750 Brielle Ave. A5
Ocean,  NJ  07712
Correspondent Contact ANTOINETTE PRUSIK
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Code
GGM  
Date Received12/12/2016
Decision Date 09/08/2017
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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