FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T— 510(k) K073431

Name: FDA 510(k) clearance K073431
Creator: U.S. Food and Drug Administration
Published: 2008-01-14

Substantially Equivalent

Tianjin New Bay Bioresearch Co., Ltd.

FDA 510(k) clearance K073431 for FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T, Substantially Equivalent on 2008-01-14. Applicant: Tianjin New Bay Bioresearch Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianjin New Bay Bioresearch Co., Ltd.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2007-12-06
Decision date: 2008-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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