The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Thymune-m.
Device ID | K780873 |
510k Number | K780873 |
Device Name: | THYMUNE-M |
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 |
---|---|---|
05056080500027 | K780873 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THYMUNE-M 75315098 not registered Dead/Abandoned |
Murex Diagnostics Corporation 1997-06-26 |