The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Thymune-t.
| Device ID | K780874 |
| 510k Number | K780874 |
| Device Name: | THYMUNE-T |
| Classification | Thyroglobulin, Antigen, Antiserum, Control |
| Applicant | BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DDC |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-30 |
| Decision Date | 1978-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080500034 | K780874 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THYMUNE-T 75315647 not registered Dead/Abandoned |
Murex Diagnostics Corporation 1997-06-26 |