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FDA 510(k)

DELFIA DIGOXIN KIT

K-Number: K924594 · 1992-12-17

ApplicantWallac OY
Decision Date1992-12-17
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DELFIA DIGOXIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 1992-12-17 under 510(k) number K924594. 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 DELFIA DIGOXIN KIT?

DELFIA DIGOXIN KIT is a medical device that received FDA 510(k) clearance on 1992-12-17. The listed applicant is Wallac OY. The 510(k) number is K924594.

When did DELFIA DIGOXIN KIT receive FDA 510(k) clearance?

DELFIA DIGOXIN KIT received FDA 510(k) clearance on 1992-12-17, under 510(k) number K924594.

Who is the listed applicant for DELFIA DIGOXIN KIT?

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

What is the FDA product code for DELFIA DIGOXIN KIT?

The FDA product code for DELFIA DIGOXIN KIT is KXT.

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Other records listing Wallac OY 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.

K131284GSP NEONATAL BIOTINIDASE KITK100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

View all 21 devices →

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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