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FDA 510(k)

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279

K-Number: K062746 · 2006-11-20

ApplicantMedicon Hellas S.A
Decision Date2006-11-20
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 is the device name listed in this FDA 510(k) record. The listed applicant is Medicon Hellas S.A. It received FDA 510(k) clearance on 2006-11-20 under 510(k) number K062746. 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-LATEX, MODELS 1418-2070, 1418-0279?

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 is a medical device that received FDA 510(k) clearance on 2006-11-20. The listed applicant is Medicon Hellas S.A. The 510(k) number is K062746.

When did FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 receive FDA 510(k) clearance?

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 received FDA 510(k) clearance on 2006-11-20, under 510(k) number K062746.

Who is the listed applicant for FERRITIN-LATEX, MODELS 1418-2070, 1418-0279?

The FDA 510(k) record lists Medicon Hellas S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FERRITIN-LATEX, MODELS 1418-2070, 1418-0279?

The FDA product code for FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 is DBF.

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Other records listing Medicon Hellas S.A 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.

K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

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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