Atlas FDA

LIAISON N-TACT PTH

FDA 510(k) clearance K033426 · decided 2004-02-12

Clearance details

K-number
K033426
Device name
LIAISON N-TACT PTH
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2003-10-27
Decision date
2004-02-12
Days to decision
108 days
Clearance type
Traditional
Product code
CEW
Device class
2
Regulation number
862.1545
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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

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Elecsys PTH , Elecsys PTH STAT (K231927)Roche Diagnostics2024-03-22
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Lumipulse G whole PTH (K190702)Fujirebio Diagnostics,Inc.2019-08-30
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (K163658)Siemens Healthcare Diagnostics, Inc.2017-05-23
IDS-iSYS Intact PTHN (K161158)Immunodiagnostic Systems , Ltd.2017-01-31
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (K150879)DiaSorin, Inc.2015-06-22
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (K133601)Siemens Healthcare Diagnostics, Inc.2014-02-05
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (K132515)DiaSorin, Inc.2013-11-08
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981)Siemens Healthcare Diagnostics2013-03-21
IDS-ISYS INTACT PTH (K103325)Immunodiagnostic Systems , Ltd.2012-02-03
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921)Ortho-Clinical Diagnostics2010-10-22

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