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FDA 510(k)

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

K-Number: K014293 · 2002-02-19

ApplicantKamiya Biomedical Co.
Decision Date2002-02-19
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 2002-02-19 under 510(k) number K014293. 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 K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET?

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2002-02-19. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K014293.

When did K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET receive FDA 510(k) clearance?

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET received FDA 510(k) clearance on 2002-02-19, under 510(k) number K014293.

Who is the listed applicant for K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET?

The FDA product code for K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET is DBF.

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Other records listing Kamiya Biomedical Co. 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.

K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLK091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORK050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETK042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CK030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CK023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

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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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