| Device Classification Name |
lipoprotein, low-density, antigen, antiserum, control
|
|---|
| 510(K) Number |
K122722 |
|---|
| Model |
05852625190; 058525641160; 05852650160
|
| Device Name |
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 |
|---|
| Applicant |
| ROCHE DIAGNOSTICS |
| 9115 hague road |
|
indianapolis,
IN
46250 0416
|
|
| Contact |
lisa k klinedinst |
| Regulation Number | 866.5600
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 09/05/2012 |
|---|
| Decision Date | 11/29/2012 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Immunology
|
|---|
| Review Advisory Committee |
Clinical Chemistry
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
