The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Tsh, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3.
| Device ID | K130469 |
| 510k Number | K130469 |
| Device Name: | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Kelly Sauer |
| Correspondent | Kelly Sauer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-04-05 |
| Summary: | summary |