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FDA 510(k)

TINA-QUANT FERRITIN GEN. 4

K-Number: K100538 · 2010-06-22

ApplicantRoche Diagnostics
Decision Date2010-06-22
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT FERRITIN GEN. 4 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2010-06-22 under 510(k) number K100538. 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 TINA-QUANT FERRITIN GEN. 4?

TINA-QUANT FERRITIN GEN. 4 is a medical device that received FDA 510(k) clearance on 2010-06-22. The listed applicant is Roche Diagnostics. The 510(k) number is K100538.

When did TINA-QUANT FERRITIN GEN. 4 receive FDA 510(k) clearance?

TINA-QUANT FERRITIN GEN. 4 received FDA 510(k) clearance on 2010-06-22, under 510(k) number K100538.

Who is the listed applicant for TINA-QUANT FERRITIN GEN. 4?

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

What is the FDA product code for TINA-QUANT FERRITIN GEN. 4?

The FDA product code for TINA-QUANT FERRITIN GEN. 4 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.K092505BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203Beckman Coulter, Inc.

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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