510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122986Substantially Equivalent

Vidas Lyme Igg

bioMerieux, Inc., Marcy L Etoile, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122986 is the FDA 510(k) clearance record for VIDAS LYME IGG, a class II device, cleared for Biomerieux S.A. on under FDA product code LSR (Reagent, Borrelia Serological Reagent). FDA records list 408 510(k) clearances for Biomerieux S.A., from to . As of , FDA records show no recalls naming K122986.

Clearance record

Decision date
Received
(160 days to decision)
Product code
LSR Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Biomerieux S.A. Chemin De L Orme, Marcy L Etoile, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LSR

Trailing 12 months
1 clearance under product code LSR in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LSR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260