Atlas FDA

LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3

FDA 510(k) clearance K121951 · decided 2013-04-04

Clearance details

K-number
K121951
Device name
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2012-07-03
Decision date
2013-04-04
Days to decision
275 days
Clearance type
Traditional
Product code
CEC
Device class
2
Regulation number
862.1695
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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VIDAS FT4 (K132058)Biomerieux S.A.2015-06-08
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859)Siemens Healthcare Diagnostics, Inc.2014-11-26
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART (K140842)Siemens Healthcare Diagnostics, Inc.2014-11-26
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244)Roche Diagnostics2014-01-27
ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (K132249)Siemens Healthcare Diagnostics, Inc.2013-09-13
ABBOTT ARCHITECT FREE T4 (K123379)Abbott Laboratories2012-11-27

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