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FDA 510(k)

LIAISON MeMed BV, LIAISON MeMed BV Control Set

K-Number: K213936 · 2022-07-14

ApplicantDiaSorin, Inc.
Decision Date2022-07-14
Product CodeQPS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON MeMed BV, LIAISON MeMed BV 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 2022-07-14 under 510(k) number K213936. The device is classified under product code QPS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON MeMed BV, LIAISON MeMed BV Control Set?

LIAISON MeMed BV, LIAISON MeMed BV Control Set is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is DiaSorin, Inc.. The 510(k) number is K213936.

When did LIAISON MeMed BV, LIAISON MeMed BV Control Set receive FDA 510(k) clearance?

LIAISON MeMed BV, LIAISON MeMed BV Control Set received FDA 510(k) clearance on 2022-07-14, under 510(k) number K213936.

Who is the listed applicant for LIAISON MeMed BV, LIAISON MeMed BV 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 MeMed BV, LIAISON MeMed BV Control Set?

The FDA product code for LIAISON MeMed BV, LIAISON MeMed BV Control Set is QPS.

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: QPS)

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.

K230944MeMed BVMeMed Diagnostics, Ltd.K222332MeMed BVMeMed Diagnostics, Ltd.K210254MeMed BVMeMed Diagnostics, Ltd.

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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