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)

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS

K-Number: K052407 · 2006-07-18

ApplicantFisher Diagnostics
Decision Date2006-07-18
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2006-07-18 under 510(k) number K052407. 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 ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS?

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Fisher Diagnostics. The 510(k) number is K052407.

When did ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS receive FDA 510(k) clearance?

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS received FDA 510(k) clearance on 2006-07-18, under 510(k) number K052407.

Who is the listed applicant for ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS?

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

What is the FDA product code for ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS?

The FDA product code for ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS 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 Fisher Diagnostics 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.

K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsK070640ARCHITECT STAT TROPONIN-1; MYOGLOBINK052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMK042924ARCHITECT STAT MYO IMMUNOASSAYK041192ARCHITECT STAT TROPONIN-I IMMUNOASSAYK041596ARCHITECT STAT CK-MB IMMUNOASSAY

View all 16 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.

↑