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)

FIDIS TM THYRO, MODEL MX002

K-Number: K061794 · 2006-11-21

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2006-11-21
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDIS TM THYRO, MODEL MX002 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Diagnostics (Bmd) SA. It received FDA 510(k) clearance on 2006-11-21 under 510(k) number K061794. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIDIS TM THYRO, MODEL MX002?

FIDIS TM THYRO, MODEL MX002 is a medical device that received FDA 510(k) clearance on 2006-11-21. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K061794.

When did FIDIS TM THYRO, MODEL MX002 receive FDA 510(k) clearance?

FIDIS TM THYRO, MODEL MX002 received FDA 510(k) clearance on 2006-11-21, under 510(k) number K061794.

Who is the listed applicant for FIDIS TM THYRO, MODEL MX002?

The FDA 510(k) record lists Biomedical Diagnostics (Bmd) SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIDIS TM THYRO, MODEL MX002?

The FDA product code for FIDIS TM THYRO, MODEL MX002 is JZO.

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 Biomedical Diagnostics (Bmd) SA 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.

K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISK100917FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEMK070458MODIFICATION TO FIDIS VASCULITIS, MODEL MX007K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006K060380FIDIS DSDNAK053383FIDIS CELIAC

View all 10 devices →

Related Devices (Code: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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.

↑