| Device Classification Name |
radioassay, vitamin b12
|
|---|
| 510(K) Number |
K121994 |
|---|
| Model |
K6442A, KC 640A
|
| 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
|
|
| 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 - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Clinical Chemistry
|
|---|
| Review Advisory Committee |
Clinical Chemistry
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
