The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Lyme Total Antibody Plus, Liaison Lyme Total Antibody Plus Control Set.
Device ID | K193051 |
510k Number | K193051 |
Device Name: | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set |
Classification | Reagent, Borrelia Serological Reagent |
Applicant | DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285 |
Contact | John C. Walter |
Correspondent | Mari Meyer DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285 |
Product Code | LSR |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-01 |
Decision Date | 2020-01-29 |
Summary: | summary |