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)

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN

K-Number: K033454 · 2004-03-22

ApplicantBrahms Diagnostica, LLC
Decision Date2004-03-22
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Brahms Diagnostica, LLC. It received FDA 510(k) clearance on 2004-03-22 under 510(k) number K033454. 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 BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN?

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN is a medical device that received FDA 510(k) clearance on 2004-03-22. The listed applicant is Brahms Diagnostica, LLC. The 510(k) number is K033454.

When did BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN receive FDA 510(k) clearance?

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN received FDA 510(k) clearance on 2004-03-22, under 510(k) number K033454.

Who is the listed applicant for BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN?

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

What is the FDA product code for BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN?

The FDA product code for BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN 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 Brahms Diagnostica, LLC 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.

K021057BRAHMS DIAGNOSTICA DYNOTEST TG-PLUSK000287BRAHMS DIAGNOSTICA LUMITEST ANTI-TPOK000286BRAHMS DIAGNOSTICA LUMITEST ANTI-TGK992791BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPOK992790BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG

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.

↑