510(k) Report

FDA applicant

Meridian Diagnostics, Inc.

Cincinnati, OH92 decisions1980–199912 recalls

FDA records 92 decisions for Meridian Diagnostics, Inc. (Cincinnati, OH) from 1980 to 1999: 92 510(k) clearances. Most are in product codes LLH (Reagents, Clostridium Difficile Toxin) and LYR (Helicobacter Pylori). Its devices cite 1 predicate, 0 of them its own earlier devices. 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Meridian Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Meridian Diagnostics, Inc. since 2007.

Recalls per year

3in 2023

2011: 12016: 12018: 12021: 12022: 12023: 3
2007high 3 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Meridian Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLHReagents, Clostridium Difficile Toxin6decisions
  • LYRHelicobacter Pylori5decisions
  • GMJAntigens, Histoplasma Capsulatum, All4decisions
  • GMKAntiserum, Positive Control, Histoplasma Capsulatum4decisions
  • GMIAntigen, Cf And / Or Id, Coccidioides Immitis4decisions
  • GMHAntiserum, Positive Control, Coccidioides Immitis3decisions

Also: KEQ (3), IGG (3), LIQ (3), KFG (2), LKS (2), JWW (2).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K953362Premier EhecMeridian Diagnostics, Inc. · 19954cite it
  • K912408Merifluor-Cryptosporidium/GiardiaMeridian Diagnostics, Inc. · 19913cite it
  • K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 19993cite it
  • K792712Para-Pak (C&S)Meridian Diagnostics, Inc. · 19802cite it
  • K983255Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 19982cite it
  • K924979Immunocard (TM) C. DifficileMeridian Diagnostics, Inc. · 19932cite it

What has FDA decided for it lately?

  • K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 19992 recalls
  • K990263Immunocard Stat! E. Coli O157:H7Meridian Diagnostics, Inc. · 1999
  • K984346Premier Type Specific HSV-2 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K984343Premier Type Specific HSV-1 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K983255Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 19981 recall
  • K982764Premier CryptosporidiumMeridian Diagnostics, Inc. · 1998
  • K982711Premier GiardiaMeridian Diagnostics, Inc. · 1998
  • K980076Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998

All 92 as Meridian Diagnostics, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K792710Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of…Oct 19, 2023Class II
  • K792710Cardinal Health Clean Stool Transportation System-For the collection, transportation…Oct 19, 2023Class II
  • K792705Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation…Oct 19, 2023Class II
  • K971585meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The…Jan 25, 2022Class II
  • K934550The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum -…Feb 8, 2021Class II
  • K904393PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER…Dec 17, 2018Class II

Other applicant names beginning “Meridian”

FDA records each applicant name separately; these may or may not be the same firm.

Meridian Bioscience, Inc. 39Meridian AG 14Meridian Medical Systems, LLC 8Meridian Medical Technologies, Inc. 6Meridian Bioscience Israel, Ltd. 3Meridian Technique, Ltd. 1Meridian Dynamics Biomedical, Inc. 1Meridian Medical 1