Curian® Shiga Toxin— 510(k) K222829

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K222829 for Curian® Shiga Toxin, Substantially Equivalent on 2023-04-17. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 2022-09-19
Decision date: 2023-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMZ

K121364 — SHIGA TOXIN QUIK CHEK2012-10-02
K121411 — SHIGA TOXIN CHEK2012-10-02
K062546 — IMMUNOCARD STAT! EHEC, MODEL 7516302007-02-14
K061889 — BIOSTAR OIA SHIGATOX2006-12-12
K023599 — IMMUNOCARD STAT! E. COLI O157 PLUS2003-01-03

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