The following data is part of a premarket notification filed by Humagen, Inc. with the FDA for Tru-trax.
| Device ID | K894851 |
| 510k Number | K894851 |
| Device Name: | TRU-TRAX |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | HUMAGEN, INC. 1500 AVON ST. EXTENDED Charlottesville, VA 22901 |
| Contact | Bryant, Phd |
| Correspondent | Bryant, Phd HUMAGEN, INC. 1500 AVON ST. EXTENDED Charlottesville, VA 22901 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-09-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRU-TRAX 73832043 1598434 Dead/Cancelled |
HUMAGEN, INC. 1989-10-17 |