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FDA 510(k)

IMMPULSE DIGOXIN ASSAY REAGENTS

K-Number: K842571 · 1984-08-16

ApplicantAktis Corp.
Decision Date1984-08-16
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE DIGOXIN ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Aktis Corp.. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842571. 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 IMMPULSE DIGOXIN ASSAY REAGENTS?

IMMPULSE DIGOXIN ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Aktis Corp.. The 510(k) number is K842571.

When did IMMPULSE DIGOXIN ASSAY REAGENTS receive FDA 510(k) clearance?

IMMPULSE DIGOXIN ASSAY REAGENTS received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842571.

Who is the listed applicant for IMMPULSE DIGOXIN ASSAY REAGENTS?

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

What is the FDA product code for IMMPULSE DIGOXIN ASSAY REAGENTS?

The FDA product code for IMMPULSE DIGOXIN ASSAY REAGENTS is KXT.

Related Clinical Trials

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Other records listing Aktis 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.

K842554IMMPULSE CORTISOL ASSAY REAGENTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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