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FDA 510(k)

LIAISON Testosterone xt

K-Number: K201908 · 2020-10-15

ApplicantDiaSorin, Inc.
Decision Date2020-10-15
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIAISON Testosterone xt is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-10-15 under 510(k) number K201908. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Testosterone xt?

LIAISON Testosterone xt is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is DiaSorin, Inc.. The 510(k) number is K201908.

When did LIAISON Testosterone xt receive FDA 510(k) clearance?

LIAISON Testosterone xt received FDA 510(k) clearance on 2020-10-15, under 510(k) number K201908.

Who is the listed applicant for LIAISON Testosterone xt?

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 Testosterone xt?

The FDA product code for LIAISON Testosterone xt is CDZ.

Other records listing DiaSorin, Inc. as applicant

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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: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK191350ACTIVE® Free Testosterone RIAImmunotech S.R.O.

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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