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FDA 510(k)

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

K-Number: K181464 · 2018-08-31

ApplicantDiaSorin, Inc.
Decision Date2018-08-31
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K181464. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is DiaSorin, Inc.. The 510(k) number is K181464.

When did LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set receive FDA 510(k) clearance?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set received FDA 510(k) clearance on 2018-08-31, under 510(k) number K181464.

Who is the listed applicant for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

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 Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

The FDA product code for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is LYR.

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)

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Related Devices (Code: LYR)

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.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181400H. PYLORI CHEK™Techlab, 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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