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FDA 510(k)

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION

K-Number: K934135 · 1994-04-06

ApplicantSyva Co.
Decision Date1994-04-06
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K934135. 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 EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION?

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is Syva Co.. The 510(k) number is K934135.

When did EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION receive FDA 510(k) clearance?

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION received FDA 510(k) clearance on 1994-04-06, under 510(k) number K934135.

Who is the listed applicant for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION?

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

What is the FDA product code for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION?

The FDA product code for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION is KXT.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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