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FDA 510(k)

ENZYME-TEST DIGOXIN

K-Number: K823199 · 1982-11-29

ApplicantIcl Scientific
Decision Date1982-11-29
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENZYME-TEST DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823199. 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 ENZYME-TEST DIGOXIN?

ENZYME-TEST DIGOXIN is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Icl Scientific. The 510(k) number is K823199.

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

ENZYME-TEST DIGOXIN received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823199.

Who is the listed applicant for ENZYME-TEST DIGOXIN?

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

What is the FDA product code for ENZYME-TEST DIGOXIN?

The FDA product code for ENZYME-TEST DIGOXIN is KXT.

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK822777THERAPEUTIC DRUG CONTROL

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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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