| Device Classification Name |
blood establishment computer software and accessories
|
|---|
| 510(k) Number |
BK010049 |
|---|
| Tradename |
Donor-ID
|
| Device Name |
Blood Establishment Computer Software and Accessories |
|---|
| Original Applicant |
| Digi-Trax Corporation |
| 1550 barclay boulevard |
|
buffalo grove,
IL
60089
|
|
| Regulation Number | 864.9165
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/26/2001 |
|---|
| Decision Date | 04/26/2002 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Hematology
|
|---|
| Review Advisory Committee |
Hematology
|
|---|
| Type |
510(k) Abbreviated
|
|---|
| Total Product Life Cycle (TPLC) |
TPLC Device Report
|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
| In Vitro Product |
No
|
|---|