The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison 25 Total-d.
Device ID | K132492 |
510k Number | K132492 |
Device Name: | LIAISON 25 TOTAL-D |
Classification | System, Test, Vitamin D |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Contact | Mari Meyer |
Correspondent | Mari Meyer DIASORIN, INC. 1951 NORTHWESTERN AVE. 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 | 2013-08-09 |
Decision Date | 2013-09-05 |
Summary: | summary |