The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Anti-hav Assay, Liaison Control Anti-hav.
Device ID | K082049 |
510k Number | K082049 |
Device Name: | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV |
Classification | Hepatitis A Test (antibody And Igm Antibody) |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
Contact | Carol A Depouw |
Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. 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 | 2008-07-18 |
Decision Date | 2008-12-05 |
Summary: | summary |