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FDA 510(k)

SENSIBEAD EIA DIGOXIN KIT

K-Number: K840673 · 1984-03-12

ApplicantTerumo Medical Corp.
Decision Date1984-03-12
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SENSIBEAD EIA DIGOXIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K840673. 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 SENSIBEAD EIA DIGOXIN KIT?

SENSIBEAD EIA DIGOXIN KIT is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Terumo Medical Corp.. The 510(k) number is K840673.

When did SENSIBEAD EIA DIGOXIN KIT receive FDA 510(k) clearance?

SENSIBEAD EIA DIGOXIN KIT received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840673.

Who is the listed applicant for SENSIBEAD EIA DIGOXIN KIT?

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

What is the FDA product code for SENSIBEAD EIA DIGOXIN KIT?

The FDA product code for SENSIBEAD EIA DIGOXIN KIT is KXT.

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Other records listing Terumo Medical 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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