ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM— 510(k) K121044

Name: FDA 510(k) clearance K121044
Creator: U.S. Food and Drug Administration
Published: 2012-05-01

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K121044 for ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM, Substantially Equivalent on 2012-05-01. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Product code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2012-04-06
Decision date: 2012-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K121044

K-number listed on FDA's recall record

Z-0569-2026 — Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test AssayClass II·Ongoing·Meridian Bioscience Inc·20251007

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121044.

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