510(k) K220456

Device
Elecsys FT4 IV
Applicant
Roche Diagnostics
510(k) number
K220456
Product code
CEC
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-07
Date received
2022-02-17
Regulation
862.1695
Classification name
Radioimmunoassay, Free Thyroxine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Bin Sun
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07613336175071Elecsys FT4 IVRoche Diagnostics GmbH2023-05-03
07613336172780Elecsys FT4 IVRoche Diagnostics GmbH2023-05-02

Other 510(k) Records For Product Code CEC

510(k)DeviceApplicantDecision date
K240273Access Free T4Beckman Coulter, Inc.2024-03-06
K182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.2018-10-04
K181233Elecsys FT4 IIIRoche Diagnostics2018-09-18
K173122Abbott Architect Free T4Abbott Laboratories2017-10-27
K152422FREND™ Free T4 Test SystemNanoentek USA, Inc.2016-02-17
K132058VIDAS FT4Biomerieux S.A.2015-06-08
K140842DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CARTSiemens Healthcare Diagnostics, Inc.2014-11-26
K140859DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENTSiemens Healthcare Diagnostics, Inc.2014-11-26
K131244ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSETRoche Diagnostics2014-01-27
K132249ADVIA CENTAUR FT4, ADVIA CENTAUR T4Siemens Healthcare Diagnostics, Inc.2013-09-13
K121951LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3DiaSorin, Inc.2013-04-04
K123379ABBOTT ARCHITECT FREE T4Abbott Laboratories2012-11-27
K083373IMMULITE 2000 FREE T4Siemens Healthcare Diagnostics, Inc.2009-02-02
K080167ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYSSiemens Healthcare Diagnostics2008-08-08
K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MODDade Behring, Inc.2008-03-13