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FDA 510(k)

CORNING FERRITIN 125I RADIOIMMUNOASSAY

K-Number: K830591 · 1983-03-24

ApplicantCorning Medical & Scientific
Decision Date1983-03-24
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CORNING FERRITIN 125I RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830591. 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 CORNING FERRITIN 125I RADIOIMMUNOASSAY?

CORNING FERRITIN 125I RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Corning Medical & Scientific. The 510(k) number is K830591.

When did CORNING FERRITIN 125I RADIOIMMUNOASSAY receive FDA 510(k) clearance?

CORNING FERRITIN 125I RADIOIMMUNOASSAY received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830591.

Who is the listed applicant for CORNING FERRITIN 125I RADIOIMMUNOASSAY?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORNING FERRITIN 125I RADIOIMMUNOASSAY?

The FDA product code for CORNING FERRITIN 125I RADIOIMMUNOASSAY is DBF.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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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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