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FDA 510(k)

FERRITIN GENERATION 2

K-Number: K031650 · 2003-07-17

ApplicantRoche Diagnostics Corp.
Decision Date2003-07-17
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERRITIN GENERATION 2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-07-17 under 510(k) number K031650. 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 FERRITIN GENERATION 2?

FERRITIN GENERATION 2 is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K031650.

When did FERRITIN GENERATION 2 receive FDA 510(k) clearance?

FERRITIN GENERATION 2 received FDA 510(k) clearance on 2003-07-17, under 510(k) number K031650.

Who is the listed applicant for FERRITIN GENERATION 2?

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

What is the FDA product code for FERRITIN GENERATION 2?

The FDA product code for FERRITIN GENERATION 2 is DBF.

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Other records listing Roche Diagnostics Corp. 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.

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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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