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FDA 510(k)

OPUS CMV-G

K-Number: K933389 · 1994-06-28

ApplicantPb Diagnostic Systems, Inc.
Decision Date1994-06-28
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OPUS CMV-G is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1994-06-28 under 510(k) number K933389. 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-G?

OPUS CMV-G is a medical device that received FDA 510(k) clearance on 1994-06-28. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K933389.

When did OPUS CMV-G receive FDA 510(k) clearance?

OPUS CMV-G received FDA 510(k) clearance on 1994-06-28, under 510(k) number K933389.

Who is the listed applicant for OPUS CMV-G?

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

What is the FDA product code for OPUS CMV-G?

The FDA product code for OPUS CMV-G is LFZ.

Other records listing Pb Diagnostic Systems, 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.

K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPAK933066OPUS ESTRADIOL

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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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