Device Classification Name |
tube, collection, capillary blood
|
510(k) Number |
K894851 |
Device Name |
TRU-TRAX |
Applicant |
HUMAGEN, INC. |
1500 AVON ST. EXTENDED |
CHARLOTTESVILLE,
VA
22901
|
|
Applicant Contact |
BRYANT, PHD |
Correspondent |
HUMAGEN, INC. |
1500 AVON ST. EXTENDED |
CHARLOTTESVILLE,
VA
22901
|
|
Correspondent Contact |
BRYANT, PHD |
Regulation Number | 864.6150
|
Classification Product Code |
|
Date Received | 07/31/1989 |
Decision Date | 09/29/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|