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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 K100031
Device Name IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
Applicant
Ind Diagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Applicant Contact JASON PENG
Correspondent
Ind Diagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Correspondent Contact JASON PENG
Regulation Number864.6550
Classification Product Code
KHE  
Date Received01/06/2010
Decision Date 07/19/2010
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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