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FDA 510(k)

DIGOXIN DG-II FPIA REAGENT SET

K-Number: K972794 · 1997-07-31

ApplicantSigma Diagnostics, Inc.
Decision Date1997-07-31
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN DG-II FPIA REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K972794. 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 DIGOXIN DG-II FPIA REAGENT SET?

DIGOXIN DG-II FPIA REAGENT SET is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K972794.

When did DIGOXIN DG-II FPIA REAGENT SET receive FDA 510(k) clearance?

DIGOXIN DG-II FPIA REAGENT SET received FDA 510(k) clearance on 1997-07-31, under 510(k) number K972794.

Who is the listed applicant for DIGOXIN DG-II FPIA REAGENT SET?

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

What is the FDA product code for DIGOXIN DG-II FPIA REAGENT SET?

The FDA product code for DIGOXIN DG-II FPIA REAGENT SET is KXT.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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