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FDA 510(k)

DUPONT DIGOXIN ASSAY REAGENTS

K-Number: K850458 · 1985-03-05

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1985-03-05
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DUPONT DIGOXIN ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K850458. 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 DUPONT DIGOXIN ASSAY REAGENTS?

DUPONT DIGOXIN ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K850458.

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

DUPONT DIGOXIN ASSAY REAGENTS received FDA 510(k) clearance on 1985-03-05, under 510(k) number K850458.

Who is the listed applicant for DUPONT DIGOXIN ASSAY REAGENTS?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

View all 253 devices →

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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