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)

AXSYM CORTISOL ASSAY

K-Number: K033731 · 2004-02-20

ApplicantFujirebio Diagnostics,Inc.
Decision Date2004-02-20
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXSYM CORTISOL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K033731. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM CORTISOL ASSAY?

AXSYM CORTISOL ASSAY is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K033731.

When did AXSYM CORTISOL ASSAY receive FDA 510(k) clearance?

AXSYM CORTISOL ASSAY received FDA 510(k) clearance on 2004-02-20, under 510(k) number K033731.

Who is the listed applicant for AXSYM CORTISOL ASSAY?

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

What is the FDA product code for AXSYM CORTISOL ASSAY?

The FDA product code for AXSYM CORTISOL ASSAY is JFT.

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 Fujirebio Diagnostics,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.

K250925ADVIA Centaur Cytokeratin Fragment 21-1K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioK192524Lumipulse G CA15-3K192380ST AIA-PACK BNPK200997Lumipulse G CA19-9-NK190702Lumipulse G whole PTH

View all 40 devices →

Related Devices (Code: JFT)

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.

K242505Elecsys Cortisol IIIRoche DiagnosticsK192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.K152227Elecsys Cortisol II, Cortisol II CalSetRoche DiagnosticsK062204ARCHITECT CORTISOL ASSAYSeradyn, Inc.K021218ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics Corp.K962559ACS CORTISOL IMMUNOASSAYCiba Corning Diagnostics Corp.

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.

↑