| Device Classification Name |
vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
|
|---|
| 510(K) Number |
K071867 |
|---|
| Device Name |
RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA |
|---|
| Applicant |
| PARAGONDX, LLC |
| 133 southcenter court |
| suite 200 |
|
morrisville,
NC
27560
|
|
| Contact |
deborah n kloos |
| Regulation Number | 864.7750
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 07/06/2007 |
|---|
| Decision Date | 04/28/2008 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Hematology
|
|---|
| Review Advisory Committee |
Toxicology
|
|---|
| statement |
statement
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
