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FDA 510(k)

125I FERRITIN RADIOIMMUNOASSAY KIT

K-Number: K812901 · 1981-12-30

ApplicantBio-Ria
Decision Date1981-12-30
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

125I FERRITIN RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Ria. It received FDA 510(k) clearance on 1981-12-30 under 510(k) number K812901. 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 125I FERRITIN RADIOIMMUNOASSAY KIT?

125I FERRITIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1981-12-30. The listed applicant is Bio-Ria. The 510(k) number is K812901.

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

125I FERRITIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1981-12-30, under 510(k) number K812901.

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

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

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

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

Related Clinical Trials

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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Other records listing Bio-Ria 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.

K801019125I-IGE RADIOIMMUNOASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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