Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K121994 |
Device Name |
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR |
Applicant |
Siemens Healthcare Diagnostics Inc. |
500 GBC DRIVE |
NEWARK,
DE
19714
|
|
Applicant Contact |
A. KATHLEEN B ENNIS |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
500 GBC DRIVE |
NEWARK,
DE
19714
|
|
Correspondent Contact |
A. KATHLEEN B ENNIS |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/06/2012 |
Decision Date | 11/30/2012 |
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
|
|
|