The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison 25 Oh Vitamin D.
Device ID | K032844 |
510k Number | K032844 |
Device Name: | LIAISON 25 OH VITAMIN D |
Classification | System, Test, Vitamin D |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
Contact | David Ikeda |
Correspondent | David Ikeda DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
Product Code | MRG |
CFR Regulation Number | 862.1825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-11 |
Decision Date | 2004-02-12 |
Summary: | summary |