Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BINAX LEGIONELLA URINARY ANTIGEN EIA

K-Number: K934965 · 1994-09-20

ApplicantBinax, Inc.
Decision Date1994-09-20
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BINAX LEGIONELLA URINARY ANTIGEN EIA is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K934965. 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 BINAX LEGIONELLA URINARY ANTIGEN EIA?

BINAX LEGIONELLA URINARY ANTIGEN EIA is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Binax, Inc.. The 510(k) number is K934965.

When did BINAX LEGIONELLA URINARY ANTIGEN EIA receive FDA 510(k) clearance?

BINAX LEGIONELLA URINARY ANTIGEN EIA received FDA 510(k) clearance on 1994-09-20, under 510(k) number K934965.

Who is the listed applicant for BINAX LEGIONELLA URINARY ANTIGEN EIA?

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

What is the FDA product code for BINAX LEGIONELLA URINARY ANTIGEN EIA?

The FDA product code for BINAX LEGIONELLA URINARY ANTIGEN EIA 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Binax, 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.

K090301BINAXNOW PBP2A TEST, MODEL 890-000K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTK091489CLEARVIEW ADVANCED STREP A , MODEL 737-430K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

View all 30 devices →

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.

↑