Cleared Traditional

ADVIA Centaur EBV-EBNA IgG

K233605 · Biokit, S.A. · Microbiology
Aug 2024
Decision
272d
Days
Class 1
Risk

About This 510(k) Submission

K233605 is an FDA 510(k) clearance for the ADVIA Centaur EBV-EBNA IgG, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Biokit, S.A. (Lli?? D?Amunt, Barcelona, ES). The FDA issued a Cleared decision on August 7, 2024, 272 days after receiving the submission on November 9, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K233605 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2023
Decision Date August 07, 2024
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLM — Test, Antigen, Nuclear, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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