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FDA 510(k)

DIGOXIN ENZYME IMMUNOASSAY

K-Number: K963835 · 1996-12-10

ApplicantDiagnostic Reagents, Inc.
Decision Date1996-12-10
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1996-12-10 under 510(k) number K963835. 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 DIGOXIN ENZYME IMMUNOASSAY?

DIGOXIN ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1996-12-10. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K963835.

When did DIGOXIN ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

DIGOXIN ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1996-12-10, under 510(k) number K963835.

Who is the listed applicant for DIGOXIN ENZYME IMMUNOASSAY?

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

What is the FDA product code for DIGOXIN ENZYME IMMUNOASSAY?

The FDA product code for DIGOXIN ENZYME IMMUNOASSAY is KXT.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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