Device Classification Name |
Dna Specimen Collection, Saliva
|
510(k) Number |
K152464 |
Device Name |
ORAcollect.Dx |
Applicant |
DNA GENOTEK INC. |
2 BEAVERBROOK ROAD |
OTTAWA,
CA
K2K 1L1
|
|
Applicant Contact |
Dan Fullerton |
Correspondent |
DNA GENOTEK INC. |
2 BEAVERBROOK ROAD |
OTTAWA,
CA
K2K 1L1
|
|
Correspondent Contact |
Dan Fullerton |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 08/31/2015 |
Decision Date | 05/26/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|