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FDA 510(k)

DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET

K-Number: K940569 · 1994-07-13

ApplicantSigma Diagnostics, Inc.
Decision Date1994-07-13
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN FPIA REAGENT SET AND CALIBRATOR 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 1994-07-13 under 510(k) number K940569. 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 FPIA REAGENT SET AND CALIBRATOR SET?

DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K940569.

When did DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET receive FDA 510(k) clearance?

DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET received FDA 510(k) clearance on 1994-07-13, under 510(k) number K940569.

Who is the listed applicant for DIGOXIN FPIA REAGENT SET AND CALIBRATOR 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 FPIA REAGENT SET AND CALIBRATOR SET?

The FDA product code for DIGOXIN FPIA REAGENT SET AND CALIBRATOR 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

View all 164 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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