TRU FLU— 510(k) K133714

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K133714 for TRU FLU, Substantially Equivalent on 2014-01-03. Applicant: Meridian Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2013-12-05
Decision date: 2014-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSZ

K252283 — Nano-Check Influenza A+B Test2026-01-15
K250398 — Innovita Flu A/B Antigen Rapid Test2025-07-03
K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System2025-04-18
K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit2023-12-05
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit2023-01-27

More clearances from Meridian Bioscience, Inc.

K243922 — Revogene2025-03-20
K230901 — Premier HpSA Flex (619096)2023-07-03
K222829 — Curian® Shiga Toxin2023-04-17
K222779 — Revogene2023-01-26
K220480 — Revogene2022-07-11

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