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 a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-03-02 under approval 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. It is manufactured by DiaSorin, Inc.. The 510(k) number is K193532.
When was LIAISON Anti-HAV Assay approved by the FDA?
LIAISON Anti-HAV Assay received FDA 510(k) clearance on 2020-03-02, under approval number K193532.
What company makes LIAISON Anti-HAV Assay?
LIAISON Anti-HAV Assay is manufactured by DiaSorin, Inc..
What is the FDA product code for LIAISON Anti-HAV Assay?
The FDA product code for LIAISON Anti-HAV Assay is LOL.
Other Devices by DiaSorin, Inc.
K160650LIAISON HAV IgM, LIAISON Control HAV IgM
K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161526LIAISON CMV IgM Serum Control Set
K161522LIAISON EBV IgM Serum Control Set
K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
Related Devices (Code: LOL)
K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.
K160650LIAISON HAV IgM, LIAISON Control HAV IgMDiaSorin, Inc.
K190428Elecsys Anti-HAV IIRoche Diagnostics
K210272LIAISON Anti-HAVDiaSorin, Inc.
K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.
K222850HAVAb IgG IIAbbott 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.