VIDAS NEPHROCHECK— 510(k) K210793

Substantially Equivalent

Biomérieux SA

FDA 510(k) clearance K210793 for VIDAS NEPHROCHECK, Substantially Equivalent on 2022-07-08. Applicant: Biomérieux SA. Device class: 2.

Clearance details

Applicant: Biomérieux SA
Product code: Code PIG
Device class: Class 2
Regulation: 21 CFR 862.1220
Advisory panel: Clinical Chemistry
Date received: 2021-03-16
Decision date: 2022-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy L'Etoile, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIG

K232761 — ProNephro AKI (NGAL)2023-12-07
K171482 — NEPHROCHECK Test System2017-11-16
K153165 — NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit2016-06-01
DEN130031 — NEPHROCHECK TEST SYSTEM2014-09-05

More clearances from Biomérieux SA

K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)2026-04-21
K200512 — ETEST Plazomicin (PLZ) (0.016-256 µg/mL)2020-05-07

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