The following data is part of a premarket notification filed by Elias U.s.a., Inc. with the FDA for Synelisa Tgab/tmab.
| Device ID | K915135 |
| 510k Number | K915135 |
| Device Name: | SYNELISA TGAB/TMAB |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-04-08 |