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FDA 510(k)

QUANTIMUNE(R) FERRITIN IRMA

K-Number: K863487 · 1986-10-01

ApplicantBio-Rad
Decision Date1986-10-01
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE(R) FERRITIN IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1986-10-01 under 510(k) number K863487. 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 QUANTIMUNE(R) FERRITIN IRMA?

QUANTIMUNE(R) FERRITIN IRMA is a medical device that received FDA 510(k) clearance on 1986-10-01. The listed applicant is Bio-Rad. The 510(k) number is K863487.

When did QUANTIMUNE(R) FERRITIN IRMA receive FDA 510(k) clearance?

QUANTIMUNE(R) FERRITIN IRMA received FDA 510(k) clearance on 1986-10-01, under 510(k) number K863487.

Who is the listed applicant for QUANTIMUNE(R) FERRITIN IRMA?

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

What is the FDA product code for QUANTIMUNE(R) FERRITIN IRMA?

The FDA product code for QUANTIMUNE(R) FERRITIN IRMA 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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