The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Toxo Igm Ii, Liaison Control Toxo Igm Ii.
Device ID | K131441 |
510k Number | K131441 |
Device Name: | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Contact | Sandra Zimniewicz |
Correspondent | Sandra Zimniewicz DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Product Code | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-20 |
Decision Date | 2013-08-09 |
Summary: | summary |