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FDA 510(k)

LIAISON Ferritin

K-Number: K193650 · 2021-09-14

ApplicantDiaSorin, Inc.
Decision Date2021-09-14
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LIAISON Ferritin is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K193650. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Ferritin?

LIAISON Ferritin is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is DiaSorin, Inc.. The 510(k) number is K193650.

When did LIAISON Ferritin receive FDA 510(k) clearance?

LIAISON Ferritin received FDA 510(k) clearance on 2021-09-14, under 510(k) number K193650.

Who is the listed applicant for LIAISON Ferritin?

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 Ferritin?

The FDA product code for LIAISON Ferritin is DBF.

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: DBF)

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.

K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, 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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