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FDA 510(k)

LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV

K-Number: K082049 · 2008-12-05

ApplicantDiaSorin, Inc.
Decision Date2008-12-05
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K082049. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV?

LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is DiaSorin, Inc.. The 510(k) number is K082049.

When did LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV receive FDA 510(k) clearance?

LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV received FDA 510(k) clearance on 2008-12-05, under 510(k) number K082049.

Who is the listed applicant for LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV?

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 ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV?

The FDA product code for LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV is LOL.

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Other records listing DiaSorin, 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.

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: LOL)

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.

K260048Elecsys Anti-HAV IgMRoche DiagnosticsK251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott LaboratoriesK223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, Inc.

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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