The following data is part of a premarket notification filed by Diasorin S.p.a. with the FDA for Diasorin Liaison Cmv Igm/igg.
Device ID | K040290 |
510k Number | K040290 |
Device Name: | DIASORIN LIAISON CMV IGM/IGG |
Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
Applicant | DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Contact | David M Ikeda |
Correspondent | David M Ikeda DIASORIN S.P.A. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Product Code | LFZ |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-06 |
Decision Date | 2005-06-01 |
Summary: | summary |