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510(k) K073431

FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T by Tianjin New Bay Bioresearch Co., Ltd. — Product Code KHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2008
Date Received
December 6, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

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