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FDA 510(k)

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM

K-Number: K890610 · 1989-06-23

ApplicantOrganon Teknika Corp.
Decision Date1989-06-23
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K890610. 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 VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM?

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Organon Teknika Corp.. The 510(k) number is K890610.

When did VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM receive FDA 510(k) clearance?

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K890610.

Who is the listed applicant for VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM?

The FDA product code for VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM is LFZ.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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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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