The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus T3.
| Device ID | K953160 |
| 510k Number | K953160 |
| Device Name: | OPUS T3 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Sheila Keady |
| Correspondent | Sheila Keady BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-07 |
| Decision Date | 1995-08-24 |