The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liason Xl1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers.
| Device ID | K141463 |
| 510k Number | K141463 |
| Device Name: | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS |
| Classification | System, Test, Vitamin D |
| Applicant | DiaSorin Inc. 1951 NORTHWESTERN AVENUE Stillwater, MN 55082 -0285 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DiaSorin Inc. 1951 NORTHWESTERN AVENUE Stillwater, MN 55082 -0285 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-03 |
| Decision Date | 2014-12-10 |
| Summary: | summary |