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FDA 510(k)

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT

K-Number: K891393 · 1989-06-23

ApplicantOrgenics, Ltd.
Decision Date1989-06-23
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Orgenics, Ltd.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K891393. 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 ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT?

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Orgenics, Ltd.. The 510(k) number is K891393.

When did ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT receive FDA 510(k) clearance?

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT received FDA 510(k) clearance on 1989-06-23, under 510(k) number K891393.

Who is the listed applicant for ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT?

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

What is the FDA product code for ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT?

The FDA product code for ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT is LFZ.

Related Clinical Trials

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.

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Other records listing Orgenics, Ltd. 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.

K895468ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGGK885344IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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