FDA Product Code LSR: Reagent, Borrelia Serological Reagent
Leading manufacturers include DiaSorin, Inc..
2
Total
2
Cleared
167d
Avg days
2021
Since
List of Reagent, Borrelia Serological Reagent devices cleared through 510(k)
2 devices
Cleared
Feb 18, 2021
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
DiaSorin, Inc.
Microbiology
167d
Cleared
Feb 18, 2021
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
DiaSorin, Inc.
Microbiology
167d
How to use this database
This page lists all FDA 510(k) submissions for Reagent, Borrelia Serological Reagent devices (product code LSR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →