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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K171484
Device Name hema-screen SPECIFIC Gold
Applicant
Immunostics Inc.,
1750 Brielle Ave.
Suite A5
Ocean,  NJ  07712
Applicant Contact Elizabeth Galella
Correspondent
Immunostics Inc.,
1750 Brielle Ave.
Suite A5
Ocean,  NJ  07712
Correspondent Contact Elizabeth Galella
Regulation Number864.6550
Classification Product Code
KHE  
Date Received05/22/2017
Decision Date 06/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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