Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
|
510(k) Number |
K122687 |
Device Name |
BLOOD CULTURE HOLDER |
Applicant |
GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Applicant Contact |
Judi Smith |
Correspondent |
GREINER BIO-ONE NORTH AMERICA, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Correspondent Contact |
Judi Smith |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 01/10/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|