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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 K051806
Device Name CARE FECAL OCCULT BLOOD TEST, MODEL KT313
Applicant
Epitope Diagnostics, Inc.
7955 Dunbrook Rd., Suite B
San Diego,  CA  92126
Applicant Contact PING GAO
Correspondent
Epitope Diagnostics, Inc.
7955 Dunbrook Rd., Suite B
San Diego,  CA  92126
Correspondent Contact PING GAO
Regulation Number864.6550
Classification Product Code
KHE  
Date Received07/05/2005
Decision Date 10/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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