ADVIA Centaur EBV-VCA IgM— 510(k) K233606

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K233606 for ADVIA Centaur EBV-VCA IgM, Substantially Equivalent on 2024-08-07. Applicant: Biokit, S.A.. Device class: 1.

Clearance details

Applicant: Biokit, S.A.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2023-11-09
Decision date: 2024-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliçà DAmunt, Barcelona, ES

Download summary PDF View on FDA.gov ↗

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K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set2017-01-04
K091260 — SERAQUEST EBV EA-D IGG TEST2009-06-08

More clearances from Biokit, S.A.

K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls2025-02-12
K233605 — ADVIA Centaur EBV-EBNA IgG2024-08-07
K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls2023-09-20
K214068 — Quantia IgE2023-02-21
K181333 — ADVIA Centaur Herpes-1 IgG2018-08-23

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