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FDA 510(k)

CEDIA DIGOXIN ASSAY (MODIFICATION)

K-Number: K920214 · 1992-03-02

ApplicantMicrogenics Corp.
Decision Date1992-03-02
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DIGOXIN ASSAY (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K920214. 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 CEDIA DIGOXIN ASSAY (MODIFICATION)?

CEDIA DIGOXIN ASSAY (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Microgenics Corp.. The 510(k) number is K920214.

When did CEDIA DIGOXIN ASSAY (MODIFICATION) receive FDA 510(k) clearance?

CEDIA DIGOXIN ASSAY (MODIFICATION) received FDA 510(k) clearance on 1992-03-02, under 510(k) number K920214.

Who is the listed applicant for CEDIA DIGOXIN ASSAY (MODIFICATION)?

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

What is the FDA product code for CEDIA DIGOXIN ASSAY (MODIFICATION)?

The FDA product code for CEDIA DIGOXIN ASSAY (MODIFICATION) is KXT.

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Other records listing Microgenics 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

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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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