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FDA 510(k)

VIDAS DIGOXIN (DIG)

K-Number: K932250 · 1993-09-10

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-09-10
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VIDAS DIGOXIN (DIG) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-09-10 under 510(k) number K932250. 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 VIDAS DIGOXIN (DIG)?

VIDAS DIGOXIN (DIG) is a medical device that received FDA 510(k) clearance on 1993-09-10. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K932250.

When did VIDAS DIGOXIN (DIG) receive FDA 510(k) clearance?

VIDAS DIGOXIN (DIG) received FDA 510(k) clearance on 1993-09-10, under 510(k) number K932250.

Who is the listed applicant for VIDAS DIGOXIN (DIG)?

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

What is the FDA product code for VIDAS DIGOXIN (DIG)?

The FDA product code for VIDAS DIGOXIN (DIG) is KXT.

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Other records listing Biomerieux Vitek, 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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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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