The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison 25 Oh Vitamin D Total Assay.
Device ID | K112725 |
510k Number | K112725 |
Device Name: | LIAISON 25 OH VITAMIN D TOTAL ASSAY |
Classification | System, Test, Vitamin D |
Applicant | DIASORIN, INC. P.O. BOX 103 Baldwin, MD 21013 |
Contact | Judi Smith |
Correspondent | Judi Smith DIASORIN, INC. P.O. BOX 103 Baldwin, MD 21013 |
Product Code | MRG |
CFR Regulation Number | 862.1825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-20 |
Decision Date | 2012-01-20 |
Summary: | summary |