VIDAS LYME IGM— 510(k) K122979

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K122979 for VIDAS LYME IGM, Substantially Equivalent on 2013-06-04. Applicant: Biomerieux S.A.. Device class: 2.

Clearance details

Applicant: Biomerieux S.A.
Product code: Product code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2012-09-26
Decision date: 2013-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy L Etoile, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.