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FDA 510(k)

SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES

K-Number: K884528 · 1989-03-08

ApplicantHeraeus Kulzer, Inc.
Decision Date1989-03-08
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K884528. 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 SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES?

SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K884528.

When did SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES receive FDA 510(k) clearance?

SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES received FDA 510(k) clearance on 1989-03-08, under 510(k) number K884528.

Who is the listed applicant for SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES?

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

What is the FDA product code for SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES?

The FDA product code for SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES is KXT.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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