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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 K102664
Device Name HEMA SCREEN ER
Applicant
IMMUNOSTICS, INC.
3505 SUNSET AVE.
OCEAN,  NJ  07712
Applicant Contact RICHARD M PEOPLES
Correspondent
IMMUNOSTICS, INC.
3505 SUNSET AVE.
OCEAN,  NJ  07712
Correspondent Contact RICHARD M PEOPLES
Regulation Number864.6550
Classification Product Code
KHE  
Date Received09/15/2010
Decision Date 01/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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