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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 K121397
Device Name OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
Applicant
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diegi,  CA  92121
Applicant Contact MARK STAVRO
Correspondent
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diegi,  CA  92121
Correspondent Contact MARK STAVRO
Regulation Number864.6550
Classification Product Code
KHE  
Date Received05/09/2012
Decision Date 12/28/2012
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
Predetermined Change
Control Plan Authorized		 No
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