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FDA 510(k)

TRU LEGIONELLA

K-Number: K113190 · 2012-02-24

ApplicantMeridian Bioscience, Inc.
Decision Date2012-02-24
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRU LEGIONELLA is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2012-02-24 under 510(k) number K113190. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRU LEGIONELLA?

TRU LEGIONELLA is a medical device that received FDA 510(k) clearance on 2012-02-24. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K113190.

When did TRU LEGIONELLA receive FDA 510(k) clearance?

TRU LEGIONELLA received FDA 510(k) clearance on 2012-02-24, under 510(k) number K113190.

Who is the listed applicant for TRU LEGIONELLA?

The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRU LEGIONELLA?

The FDA product code for TRU LEGIONELLA is MJH.

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Other records listing Meridian Bioscience, Inc. as applicant

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Related Devices (Code: MJH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/SK163273TRU LegionellaMeridian Bioscience, Inc.K061496SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TESTSa Scientific , Ltd.K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012Inverness Medical Professional DiagnosticsK033051LEGIONELLA PNEUMOPHILA IGG/IGMTrinity Biotech USAK991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTIntracel Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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