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FDA 510(k)

DIGOXIN-EIA-XT

K-Number: K896863 · 1990-02-13

ApplicantIn Vitro Diagnostics, Inc.
Decision Date1990-02-13
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN-EIA-XT is the device name listed in this FDA 510(k) record. The listed applicant is In Vitro Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-02-13 under 510(k) number K896863. 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-EIA-XT?

DIGOXIN-EIA-XT is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is In Vitro Diagnostics, Inc.. The 510(k) number is K896863.

When did DIGOXIN-EIA-XT receive FDA 510(k) clearance?

DIGOXIN-EIA-XT received FDA 510(k) clearance on 1990-02-13, under 510(k) number K896863.

Who is the listed applicant for DIGOXIN-EIA-XT?

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

What is the FDA product code for DIGOXIN-EIA-XT?

The FDA product code for DIGOXIN-EIA-XT is KXT.

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Other records listing In Vitro Diagnostics, 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.

K896867THYROID STIMULATING HORMONE-EIA-XTK896866LUTEINIZING HORMONE-EIA-XTK896865VITRO T4-EIA-XTK896925T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KITK896864FOLLICLE STIMULATING HORMONE-EIA-XTK873832REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801

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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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