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


Device Classification Name

reagent, occult blood

510(k) Number K073431
Device Name FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
3108 avenida olmeda
carlsbad, 
CA 
92009

Applicant Contact armando torrescano
Correspondent
Tianjin New Bay Bioresearch Co., Ltd.
3108 avenida olmeda
carlsbad, 
CA 
92009

Correspodent Contact armando torrescano
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 12/06/2007
Decision Date 01/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No