| Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
|---|
| 510(K) Number |
K122534 |
|---|
| Model |
L3PCVM
|
| Device Name |
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL |
|---|
| Applicant |
| SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 511 benedict ave. |
|
tarrytown,
NY
10591
|
|
| Contact |
garo mimaryan |
| Regulation Number | 862.1660
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/20/2012 |
|---|
| Decision Date | 03/14/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Clinical Chemistry
|
|---|
| Review Advisory Committee |
Immunology
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Abbreviated
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
