| Device Classification Name |
alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes
|
|---|
| 510(K) Number |
K121907 |
|---|
| Model |
DF 150, DC150
|
| Device Name |
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR |
|---|
| Applicant |
| SIEMENS HEALTHCARE DIAGNOSTICS |
| p.o. box 6101, mailstap 514 |
|
newark,
DE
19714
|
|
| Contact |
rose t marinelli |
| Regulation Number | 862.1050
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 06/29/2012 |
|---|
| Decision Date | 07/23/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| 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
|
|---|
|
|
