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FDA 510(k)

OREIA-Q-DIG

K-Number: K802358 · 1980-10-10

ApplicantOrganon, Inc.
Decision Date1980-10-10
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OREIA-Q-DIG is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802358. 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 OREIA-Q-DIG?

OREIA-Q-DIG is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Organon, Inc.. The 510(k) number is K802358.

When did OREIA-Q-DIG receive FDA 510(k) clearance?

OREIA-Q-DIG received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802358.

Who is the listed applicant for OREIA-Q-DIG?

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

What is the FDA product code for OREIA-Q-DIG?

The FDA product code for OREIA-Q-DIG is KXT.

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Other records listing Organon, 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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