Atlas FDA

LIAISON Testosterone xt

FDA 510(k) clearance K201908 · decided 2020-10-15

Clearance details

K-number
K201908
Device name
LIAISON Testosterone xt
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2020-07-09
Decision date
2020-10-15
Days to decision
98 days
Clearance type
Special
Product code
CDZ
Device class
1
Regulation number
862.1680
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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IDS-iSYS Total Testosterone (K252728)Immunodiagnostic Systems Limited2026-04-15
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ACTIVE® Free Testosterone RIA (K191350)Immunotech S.R.O.2019-12-20
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533)Siemens Healthcare Diagnostics, Inc.2019-08-28
IDS SHBG (K190121)Immunodiagnostic Systems , Ltd.2019-06-17
FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521)Qualigen, Inc.2019-01-29
Free Testosterone AccuBind ELISA Test System (K181017)Monobind, Inc.2018-07-20
FREND Testosterone Test System (K153577)Nanoentek USA, Inc.2016-10-14
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (K151986)Siemens Healthcare Diagnostics, Inc.2016-06-29

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008)DiaSorin, Inc.2025-12-19
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041)DiaSorin, Inc.2025-12-19
LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021)DiaSorin, Inc.2025-10-10
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020)DiaSorin, Inc.2025-10-10
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021)DiaSorin, Inc.2025-10-10