The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Hav Igm, Liaison Control Hav Igm.
Device ID | K160650 |
510k Number | K160650 |
Device Name: | LIAISON HAV IgM, LIAISON Control HAV IgM |
Classification | Hepatitis A Test (antibody And Igm Antibody) |
Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
Contact | John Walter |
Correspondent | Carol A. Depouw DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
Product Code | LOL |
CFR Regulation Number | 866.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-08 |
Decision Date | 2016-08-25 |
Summary: | summary |