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FDA 510(k)

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

K-Number: K991074 · 1999-12-21

ApplicantIntracel Corp.
Decision Date1999-12-21
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Intracel Corp.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K991074. 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 BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST?

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Intracel Corp.. The 510(k) number is K991074.

When did BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST receive FDA 510(k) clearance?

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST received FDA 510(k) clearance on 1999-12-21, under 510(k) number K991074.

Who is the listed applicant for BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST?

The FDA 510(k) record lists Intracel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST?

The FDA product code for BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST is MJH.

Related Clinical Trials

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.

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Other records listing Intracel Corp. 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.

K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITK990664PRIMA SYSTEM - OLD, BARTELS ELISA - NEWK982311BARTELS CINAKIT CMV ANTIGENEMIAK933878ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT

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

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

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