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FDA 510(k)

ABBOTT ARCHITECT FERRITIN

K-Number: K983759 · 1998-12-07

ApplicantAbbott Laboratories
Decision Date1998-12-07
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ABBOTT ARCHITECT FERRITIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K983759. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT ARCHITECT FERRITIN?

ABBOTT ARCHITECT FERRITIN is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Abbott Laboratories. The 510(k) number is K983759.

When did ABBOTT ARCHITECT FERRITIN receive FDA 510(k) clearance?

ABBOTT ARCHITECT FERRITIN received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983759.

Who is the listed applicant for ABBOTT ARCHITECT FERRITIN?

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

What is the FDA product code for ABBOTT ARCHITECT FERRITIN?

The FDA product code for ABBOTT ARCHITECT FERRITIN is DBF.

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Related Devices (Code: DBF)

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.

K193650LIAISON FerritinDiaSorin, Inc.K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical CompanyK110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics

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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