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FDA 510(k)

FERRITIN RADIOIMMUNOASSAY

K-Number: K792442 · 1979-12-18

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1979-12-18
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERRITIN RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-12-18 under 510(k) number K792442. 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 RADIOIMMUNOASSAY?

FERRITIN RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1979-12-18. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K792442.

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

FERRITIN RADIOIMMUNOASSAY received FDA 510(k) clearance on 1979-12-18, under 510(k) number K792442.

Who is the listed applicant for FERRITIN RADIOIMMUNOASSAY?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FERRITIN RADIOIMMUNOASSAY?

The FDA product code for FERRITIN RADIOIMMUNOASSAY is DBF.

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Other records listing Dade, Baxter Travenol Diagnostics, Inc. as applicant

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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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