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FDA 510(k)

LEGIONELLA STAT IGG/IGM TEST KIT

K-Number: K911356 · 1992-07-30

ApplicantWhittaker Bioproducts, Inc.
Decision Date1992-07-30
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA STAT IGG/IGM TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1992-07-30 under 510(k) number K911356. 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 LEGIONELLA STAT IGG/IGM TEST KIT?

LEGIONELLA STAT IGG/IGM TEST KIT is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K911356.

When did LEGIONELLA STAT IGG/IGM TEST KIT receive FDA 510(k) clearance?

LEGIONELLA STAT IGG/IGM TEST KIT received FDA 510(k) clearance on 1992-07-30, under 510(k) number K911356.

Who is the listed applicant for LEGIONELLA STAT IGG/IGM TEST KIT?

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

What is the FDA product code for LEGIONELLA STAT IGG/IGM TEST KIT?

The FDA product code for LEGIONELLA STAT IGG/IGM TEST KIT is MJH.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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.

K9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK905468PYLORI-G FIAX TEST KITK904738PYLORI STAT TEST KIT

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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.K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012Inverness Medical Professional DiagnosticsK033051LEGIONELLA PNEUMOPHILA IGG/IGMTrinity Biotech USA

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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