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FDA 510(k)

MODIFICATION OF OPUS FERRITIN TEST SYSTEM

K-Number: K973202 · 1997-09-12

ApplicantBehring Diagnostics, Inc.
Decision Date1997-09-12
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF OPUS FERRITIN TEST SYSTEM 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 1997-09-12 under 510(k) number K973202. 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 MODIFICATION OF OPUS FERRITIN TEST SYSTEM?

MODIFICATION OF OPUS FERRITIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-12. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K973202.

When did MODIFICATION OF OPUS FERRITIN TEST SYSTEM receive FDA 510(k) clearance?

MODIFICATION OF OPUS FERRITIN TEST SYSTEM received FDA 510(k) clearance on 1997-09-12, under 510(k) number K973202.

Who is the listed applicant for MODIFICATION OF OPUS FERRITIN TEST SYSTEM?

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 MODIFICATION OF OPUS FERRITIN TEST SYSTEM?

The FDA product code for MODIFICATION OF OPUS FERRITIN TEST SYSTEM is DBF.

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Other records listing Behring Diagnostics, Inc. as applicant

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K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENTK972011OPUS ETHANOL

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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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