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FDA 510(k)

EPSILON DIGOXIN TEST KIT

K-Number: K842655 · 1984-08-16

ApplicantBeckman Instruments, Inc.
Decision Date1984-08-16
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EPSILON DIGOXIN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842655. 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 EPSILON DIGOXIN TEST KIT?

EPSILON DIGOXIN TEST KIT is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K842655.

When did EPSILON DIGOXIN TEST KIT receive FDA 510(k) clearance?

EPSILON DIGOXIN TEST KIT received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842655.

Who is the listed applicant for EPSILON DIGOXIN TEST KIT?

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

What is the FDA product code for EPSILON DIGOXIN TEST KIT?

The FDA product code for EPSILON DIGOXIN TEST KIT is KXT.

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Other records listing Beckman Instruments, Inc. as applicant

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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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