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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Occult Blood Analyzer
510(k) Number K092330
Device Name OC-SENSOR DIANA IFOB TEST
Applicant
Polymedco Cancer Diagnostics LLC
510 Furnace Dock Rd
Cortlandt Manor,  NY  10567
Applicant Contact Candice Prowse
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact Candice Prowse
Regulation Number864.6550
Classification Product Code
OOX  
Date Received08/04/2009
Decision Date 01/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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