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FDA 510(k)

OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT

K-Number: K963170 · 1996-12-02

ApplicantOlympus America, Inc.
Decision Date1996-12-02
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1996-12-02 under 510(k) number K963170. 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 OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT?

OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT is a medical device that received FDA 510(k) clearance on 1996-12-02. The listed applicant is Olympus America, Inc.. The 510(k) number is K963170.

When did OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT receive FDA 510(k) clearance?

OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT received FDA 510(k) clearance on 1996-12-02, under 510(k) number K963170.

Who is the listed applicant for OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT?

The FDA product code for OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT is DBF.

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Other records listing Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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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