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FDA 510(k)

LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG

K-Number: K081685 · 2008-11-18

ApplicantDiaSorin, Inc.
Decision Date2008-11-18
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2008-11-18 under 510(k) number K081685. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG?

LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG is a medical device that received FDA 510(k) clearance on 2008-11-18. The listed applicant is DiaSorin, Inc.. The 510(k) number is K081685.

When did LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG receive FDA 510(k) clearance?

LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG received FDA 510(k) clearance on 2008-11-18, under 510(k) number K081685.

Who is the listed applicant for LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG?

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

What is the FDA product code for LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG?

The FDA product code for LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG is MXJ.

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Other records listing DiaSorin, Inc. as applicant

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K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXK231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTK223403LIAISON Anti-HAV; LIAISON XSK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusK213936LIAISON MeMed BV, LIAISON MeMed BV Control SetK193650LIAISON Ferritin

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Related Devices (Code: MXJ)

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.

K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.K220923Elecsys HSV-1 IgG (08948844160)Roche DiagnosticsK181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.K120625ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSVRoche DiagnosticsK120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad Laboratories

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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