The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liason 1-84 Pth Assay, Liason 1-84 Pth Control Set, Liason 1-84 Pth Calibration Verifiers.
| Device ID | K150879 |
| 510k Number | K150879 |
| Device Name: | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -1482 |
| Contact | John Walter |
| Correspondent | Carol A Depouw DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -1482 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-01 |
| Decision Date | 2015-06-22 |
| Summary: | summary |