ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500


Device Classification Name

dna specimen collection, saliva

510(k) Number K110701
Device Name ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
Applicant
DNA GENOTEK INC
2 beaverbrook road
ottawa ontario, 

CA

k2k 1l1

Applicant Contact chantal hemens-davis
Correspondent
DNA GENOTEK INC
2 beaverbrook road
ottawa ontario, 

CA

k2k 1l1

Correspodent Contact chantal hemens-davis
Regulation Number 862.1675
Classification Product Code
OYJ  
Date Received 03/14/2011
Decision Date 12/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No