| Device Classification Name |
test, factor v leiden mutations, genomic dna pcr
|
|---|
| 510(K) Number |
K033607 |
|---|
| Device Name |
FACTOR V LEIDEN KIT |
|---|
| Applicant |
| ROCHE DIAGNOSTICS CORP. |
| 9115 hague rd. |
|
indianapolis,
IN
46250
|
|
| Contact |
robert a gregg |
| Regulation Number | 864.7280
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/17/2003 |
|---|
| Decision Date | 12/17/2003 |
|---|
| Decision |
de novo petitions granted (AN) |
|---|
| Classification Advisory Committee |
Hematology
|
|---|
| Review Advisory Committee |
Hematology
|
|---|
| FOI Item |
Approval Letter
|
| Type |
De Novo Petitions Granted
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
