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FDA 510(k)

ORTHO CMV-G ANTIBODY ELISA TEST

K-Number: K905078 · 1990-12-17

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1990-12-17
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO CMV-G ANTIBODY ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-12-17 under 510(k) number K905078. 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 ORTHO CMV-G ANTIBODY ELISA TEST?

ORTHO CMV-G ANTIBODY ELISA TEST is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K905078.

When did ORTHO CMV-G ANTIBODY ELISA TEST receive FDA 510(k) clearance?

ORTHO CMV-G ANTIBODY ELISA TEST received FDA 510(k) clearance on 1990-12-17, under 510(k) number K905078.

Who is the listed applicant for ORTHO CMV-G ANTIBODY ELISA TEST?

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

What is the FDA product code for ORTHO CMV-G ANTIBODY ELISA TEST?

The FDA product code for ORTHO CMV-G ANTIBODY ELISA TEST is LFZ.

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Other records listing Ortho 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)K951100ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)

View all 126 devices →

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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