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FDA 510(k)

OPUS CMV TEST SYSTEM-MODIFICATION

K-Number: K963084 · 1996-10-09

ApplicantBehring Diagnostics, Inc.
Decision Date1996-10-09
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OPUS CMV TEST SYSTEM-MODIFICATION 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 1996-10-09 under 510(k) number K963084. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS CMV TEST SYSTEM-MODIFICATION?

OPUS CMV TEST SYSTEM-MODIFICATION is a medical device that received FDA 510(k) clearance on 1996-10-09. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K963084.

When did OPUS CMV TEST SYSTEM-MODIFICATION receive FDA 510(k) clearance?

OPUS CMV TEST SYSTEM-MODIFICATION received FDA 510(k) clearance on 1996-10-09, under 510(k) number K963084.

Who is the listed applicant for OPUS CMV TEST SYSTEM-MODIFICATION?

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 OPUS CMV TEST SYSTEM-MODIFICATION?

The FDA product code for OPUS CMV TEST SYSTEM-MODIFICATION is LFZ.

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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: LFZ)

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.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A

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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