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)

GENTIAN CYSTATIN C IMMUNOASSAY

K-Number: K081875 · 2008-08-20

ApplicantGentian AS
Decision Date2008-08-20
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENTIAN CYSTATIN C IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Gentian AS. It received FDA 510(k) clearance on 2008-08-20 under 510(k) number K081875. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTIAN CYSTATIN C IMMUNOASSAY?

GENTIAN CYSTATIN C IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2008-08-20. The listed applicant is Gentian AS. The 510(k) number is K081875.

When did GENTIAN CYSTATIN C IMMUNOASSAY receive FDA 510(k) clearance?

GENTIAN CYSTATIN C IMMUNOASSAY received FDA 510(k) clearance on 2008-08-20, under 510(k) number K081875.

Who is the listed applicant for GENTIAN CYSTATIN C IMMUNOASSAY?

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

What is the FDA product code for GENTIAN CYSTATIN C IMMUNOASSAY?

The FDA product code for GENTIAN CYSTATIN C IMMUNOASSAY is NDY.

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 Gentian AS 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.

K071388GENTIAN CYSTATIN C IMMUNOASSAY

Related Devices (Code: NDY)

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.

K242585Cystatin CSENTINEL CH. SpAK181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbHK161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)K111664DIAZYME CYSTATIN C POC TEST KITDiazyme LaboratoriesK093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLKamiya Biomedical Co.

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.

↑