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FDA 510(k)

AFFINITY(TM) FERRITIN IMMUNIT(TM)

K-Number: K885074 · 1989-01-04

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1989-01-04
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AFFINITY(TM) FERRITIN IMMUNIT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1989-01-04 under 510(k) number K885074. 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 AFFINITY(TM) FERRITIN IMMUNIT(TM)?

AFFINITY(TM) FERRITIN IMMUNIT(TM) is a medical device that received FDA 510(k) clearance on 1989-01-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K885074.

When did AFFINITY(TM) FERRITIN IMMUNIT(TM) receive FDA 510(k) clearance?

AFFINITY(TM) FERRITIN IMMUNIT(TM) received FDA 510(k) clearance on 1989-01-04, under 510(k) number K885074.

Who is the listed applicant for AFFINITY(TM) FERRITIN IMMUNIT(TM)?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY(TM) FERRITIN IMMUNIT(TM)?

The FDA product code for AFFINITY(TM) FERRITIN IMMUNIT(TM) is DBF.

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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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