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FDA 510(k)

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

K-Number: K070522 · 2007-03-15

ApplicantInverness Medical Professional Diagnostics
Decision Date2007-03-15
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical Professional Diagnostics. It received FDA 510(k) clearance on 2007-03-15 under 510(k) number K070522. 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 MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012?

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 is a medical device that received FDA 510(k) clearance on 2007-03-15. The listed applicant is Inverness Medical Professional Diagnostics. The 510(k) number is K070522.

When did MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 receive FDA 510(k) clearance?

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 received FDA 510(k) clearance on 2007-03-15, under 510(k) number K070522.

Who is the listed applicant for MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012?

The FDA 510(k) record lists Inverness Medical Professional Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012?

The FDA product code for MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 is MJH.

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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.K113190TRU LEGIONELLAMeridian Bioscience, Inc.K061496SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TESTSa Scientific , Ltd.K033051LEGIONELLA 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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