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FDA 510(k)

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT

K-Number: K983151 · 1998-11-05

ApplicantBeckman Coulter, Inc.
Decision Date1998-11-05
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 1998-11-05 under 510(k) number K983151. 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 IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT?

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT is a medical device that received FDA 510(k) clearance on 1998-11-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K983151.

When did IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT receive FDA 510(k) clearance?

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT received FDA 510(k) clearance on 1998-11-05, under 510(k) number K983151.

Who is the listed applicant for IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT?

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

What is the FDA product code for IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT?

The FDA product code for IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT is KXT.

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Other records listing Beckman Coulter, Inc. as applicant

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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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