Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K111260 |
Device Name |
A/C ENZYMATIC VITAMIN B6 ASSAY |
Applicant |
ANTICANCER INC |
7917 OSTROW ST. |
SAN DIEGO,
CA
92111
|
|
Applicant Contact |
QINGHONG HAN |
Correspondent |
ANTICANCER INC |
7917 OSTROW ST. |
SAN DIEGO,
CA
92111
|
|
Correspondent Contact |
QINGHONG HAN |
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 05/05/2011 |
Decision Date | 07/26/2012 |
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
|
|
|