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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 K881907
Device Name HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
Applicant
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Applicant Contact J OLSIEWSKI
Correspondent
Enzo Biochem, Inc.
325 Hudson St.
New York,  NY  10013
Correspondent Contact J OLSIEWSKI
Regulation Number864.6550
Classification Product Code
KHE  
Date Received05/06/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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