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FDA 510(k)

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

K-Number: K023058 · 2002-10-24

ApplicantSeradyn
Decision Date2002-10-24
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K023058. 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 QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM?

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Seradyn. The 510(k) number is K023058.

When did QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM receive FDA 510(k) clearance?

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM received FDA 510(k) clearance on 2002-10-24, under 510(k) number K023058.

Who is the listed applicant for QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM?

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

What is the FDA product code for QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM?

The FDA product code for QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM 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 Seradyn 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.

K030405QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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