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FDA 510(k)

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

K-Number: K033007 · 2003-11-14

ApplicantBayer Diagnostics Corp.
Decision Date2003-11-14
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2003-11-14 under 510(k) number K033007. 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 BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM?

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-14. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K033007.

When did BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM receive FDA 510(k) clearance?

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM received FDA 510(k) clearance on 2003-11-14, under 510(k) number K033007.

Who is the listed applicant for BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM?

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

What is the FDA product code for BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM?

The FDA product code for BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM is KXT.

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Other records listing Bayer Diagnostics Corp. 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.

K033379BAYER SPECIAL CHEMISTRY CONTROLSK033380BAYER SPECIAL CHEMISTRY CALIBRATORSK031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLSK023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

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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.

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