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FDA 510(k)

LIAISON Anti-HAV Assay

K-Number: K193532 · 2020-03-02

ApplicantDiaSorin, Inc.
Decision Date2020-03-02
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON Anti-HAV Assay is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K193532. 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 Anti-HAV Assay is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is DiaSorin, Inc.. The 510(k) number is K193532.

When did LIAISON Anti-HAV Assay receive FDA 510(k) clearance?

LIAISON Anti-HAV Assay received FDA 510(k) clearance on 2020-03-02, under 510(k) number K193532.

Who is the listed applicant for LIAISON Anti-HAV Assay?

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?

The FDA product code for LIAISON Anti-HAV Assay is LOL.

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.

PMA P250039ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGMPMA P220034ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGGK260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXPMA P180047TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSISPMA P190017Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)PMA P180049Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

View all 43 devices →

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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