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FDA 510(k)

FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS

K-Number: K812786 · 1981-10-23

ApplicantCorning Medical & Scientific
Decision Date1981-10-23
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS 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 1981-10-23 under 510(k) number K812786. 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(125I) RADIOIMMUNOASSAY TEST SYS?

FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Corning Medical & Scientific. The 510(k) number is K812786.

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

FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812786.

Who is the listed applicant for FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS?

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 FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS?

The FDA product code for FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS 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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