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FDA 510(k)

VENTREZYME DIGOXIN IMMUNOASSAY DIGOX

K-Number: K833878 · 1984-01-13

ApplicantVxr, Inc.
Decision Date1984-01-13
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VENTREZYME DIGOXIN IMMUNOASSAY DIGOX is the device name listed in this FDA 510(k) record. The listed applicant is Vxr, Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833878. 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 VENTREZYME DIGOXIN IMMUNOASSAY DIGOX?

VENTREZYME DIGOXIN IMMUNOASSAY DIGOX is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Vxr, Inc.. The 510(k) number is K833878.

When did VENTREZYME DIGOXIN IMMUNOASSAY DIGOX receive FDA 510(k) clearance?

VENTREZYME DIGOXIN IMMUNOASSAY DIGOX received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833878.

Who is the listed applicant for VENTREZYME DIGOXIN IMMUNOASSAY DIGOX?

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

What is the FDA product code for VENTREZYME DIGOXIN IMMUNOASSAY DIGOX?

The FDA product code for VENTREZYME DIGOXIN IMMUNOASSAY DIGOX is KXT.

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Other records listing Vxr, 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.

K853703VENTREZYME T3 IMMUNOASSAY T3K853748VENTRESCREEN HCG URINEK841456VENTREXYME EIA CONTROLS IMMUNOASSAYK840473VENTREZYME T4 IMMUNOASSAY T4K833960VENTREX PREGNANCY TEST KIT ENZYMEK833989VENTREZYME THEOPHYLLINE IMMUNOASSAY

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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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