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 |