The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison N-tact Pth Gen Ii, Control Set, Calibration Verifiers.
| Device ID | K132515 |
| 510k Number | K132515 |
| Device Name: | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-11-08 |
| Summary: | summary |