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)

RANDOX DIGOXIN

K-Number: K011302 · 2001-07-02

ApplicantRandox Laboratories, Ltd.
Decision Date2001-07-02
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2001-07-02 under 510(k) number K011302. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX DIGOXIN?

RANDOX DIGOXIN is a medical device that received FDA 510(k) clearance on 2001-07-02. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K011302.

When did RANDOX DIGOXIN receive FDA 510(k) clearance?

RANDOX DIGOXIN received FDA 510(k) clearance on 2001-07-02, under 510(k) number K011302.

Who is the listed applicant for RANDOX DIGOXIN?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RANDOX DIGOXIN?

The FDA product code for RANDOX DIGOXIN is KXT.

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 Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

View all 113 devices →

Related Devices (Code: KXT)

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.

K193397ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc.K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche DiagnosticsK102346RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.K093441DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435Siemens Healthcare DiagnosticsK082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01Biokit, S.A.K061249AXSYM DIGOXIN IIIAbbott Laboratories

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.

↑