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FDA 510(k)

N LATEX FERRITIN

K-Number: K950707 · 1995-03-27

ApplicantBehring Diagnostics, Inc.
Decision Date1995-03-27
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N LATEX FERRITIN is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-03-27 under 510(k) number K950707. 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 N LATEX FERRITIN?

N LATEX FERRITIN is a medical device that received FDA 510(k) clearance on 1995-03-27. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K950707.

When did N LATEX FERRITIN receive FDA 510(k) clearance?

N LATEX FERRITIN received FDA 510(k) clearance on 1995-03-27, under 510(k) number K950707.

Who is the listed applicant for N LATEX FERRITIN?

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

What is the FDA product code for N LATEX FERRITIN?

The FDA product code for N LATEX FERRITIN is DBF.

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Other records listing Behring Diagnostics, 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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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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