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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 K063673
Device Name INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
Applicant
INNOVACON, INC.
4106 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
INNOVACON, INC.
4106 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD TUNG
Regulation Number864.6550
Classification Product Code
KHE  
Date Received12/11/2006
Decision Date 03/05/2007
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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