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FDA 510(k)

NEIA-FERRITIN ENZYMEIMMUNOASSAY

K-Number: K780490 · 1978-04-10

ApplicantNew England Immunology Assoc.
Decision Date1978-04-10
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NEIA-FERRITIN ENZYMEIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is New England Immunology Assoc.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K780490. 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 NEIA-FERRITIN ENZYMEIMMUNOASSAY?

NEIA-FERRITIN ENZYMEIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is New England Immunology Assoc.. The 510(k) number is K780490.

When did NEIA-FERRITIN ENZYMEIMMUNOASSAY receive FDA 510(k) clearance?

NEIA-FERRITIN ENZYMEIMMUNOASSAY received FDA 510(k) clearance on 1978-04-10, under 510(k) number K780490.

Who is the listed applicant for NEIA-FERRITIN ENZYMEIMMUNOASSAY?

The FDA 510(k) record lists New England Immunology Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEIA-FERRITIN ENZYMEIMMUNOASSAY?

The FDA product code for NEIA-FERRITIN ENZYMEIMMUNOASSAY is DBF.

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Other records listing New England Immunology Assoc. 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.

K813288NEIA TRANSFERRIN ENZYMEIMMUNOASSAYK811757NEIA PAP ENZYMEIMMUNOASSAYK790490NEIA-FERRITIN ENZYMEIMMUNASSAY 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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