Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K160657 |
Device Name |
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube |
Applicant |
BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
Branden Reid |
Correspondent |
BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
Branden Reid |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 03/08/2016 |
Decision Date | 09/23/2016 |
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
|
|
|