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FDA 510(k)

VIDAS CMV IGG ASSAY

K-Number: K920661 · 1993-02-12

ApplicantVitek Systems, Inc.
Decision Date1993-02-12
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS CMV IGG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K920661. 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 VIDAS CMV IGG ASSAY?

VIDAS CMV IGG ASSAY is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K920661.

When did VIDAS CMV IGG ASSAY receive FDA 510(k) clearance?

VIDAS CMV IGG ASSAY received FDA 510(k) clearance on 1993-02-12, under 510(k) number K920661.

Who is the listed applicant for VIDAS CMV IGG ASSAY?

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

What is the FDA product code for VIDAS CMV IGG ASSAY?

The FDA product code for VIDAS CMV IGG ASSAY is LFZ.

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Other records listing Vitek 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.

K921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYK912371BIOMERIEUX RSV DIRECT IF KIT

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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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