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 |