FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST— 510(k) K063693

Substantially Equivalent

New Bay Bioresearch Co. , Ltd.

FDA 510(k) clearance K063693 for FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST, Substantially Equivalent on 2007-05-11. Applicant: New Bay Bioresearch Co. , Ltd..

Clearance details

Applicant: New Bay Bioresearch Co. , Ltd.
Product code: Code KHE
Advisory panel: Hematology
Date received: 2006-12-13
Decision date: 2007-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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