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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK110309
Test Name AllSource IFOB One Step Rapid Test  
Manufacturer NameORIENT GENE BIOTECH
Consumer Information Phone Number1(888)600-0886
Test TypeFecal occult blood
Effective Date09/24/2018
Device Classification Name reagent, occult blood
510(k) Number K110309
Device Name FOB ONE STEP RAPID TEST
Applicant
ORIENT GENE BIOTECH
150 CHERRY LANE RD
EAST STROUDSBURG,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
ORIENT GENE BIOTECH
150 CHERRY LANE RD
EAST STROUDSBURG,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number864.6550
Classification Product Code
KHE  
Date Received02/02/2011
Decision Date 09/14/2011
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
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