FOB ONE STEP RAPID TEST


Device Classification Name

reagent, occult blood

510(k) Number K110309
Device Name FOB ONE STEP RAPID TEST
Applicant
ORIENT GENE BIOTECH
150 cherry lane rd
east stroudsburg, 
PA 
18301

Applicant Contact gary lehnus
Correspondent
ORIENT GENE BIOTECH
150 cherry lane rd
east stroudsburg, 
PA 
18301

Correspodent Contact gary lehnus
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 02/02/2011
Decision Date 09/14/2011
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