ClearanceBrief
Panels › Clinical Chemistry › Product code KLI · Class 2

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Regulation 862.1700

0510(k)s in 12 months (86 all time)
1recalls in 12 months (12 all time)
10recalls that name a 510(k)
Get daily alerts for KLISample briefCSV

Top companies in KLI

Company510(k)sRecalls
Syva Co.140
Microgenics Corp.60
Beckman Coulter, Inc.14
Ortho-Clinical Diagnostics, Inc.14
Abbott Laboratories40
Technicon Instruments Corp.40
Bio-Rad20
Biocheck, Inc.11
Biocircuits Corp.20
Biotecx Laboratories, Inc.20
DateFirm and productCodeLinked 510(k)
Apr 22, 2026Beckman Coulter, Inc.
Access Total T4 Calibrator, Catalog No. 33805
Open, Classified		 KLIK023369
Mar 15, 2024Beckman Coulter, Inc.
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Open, Classified		 KLIK023369
Nov 10, 2021BioCheck, Inc.
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. T
Terminated		 KLIK991432
Oct 18, 2021DRG International, Inc.
Total Thyroxine (T4) ELISA; REF EIA-1781
Open, Classified		 KLIK991432
Mar 10, 2020Ortho Clinical Diagnostics
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Terminated		 KLIK160495
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Terminated		 KLINone listed
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 KLIK061655
Jun 2, 2016ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For th
Terminated		 KLIK964721
May 21, 2014Ortho-Clinical Diagnostics
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodi
Terminated		 KLINone listed
Aug 16, 2011Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quant
Terminated		 KLIK023369
Apr 12, 2011Beckman Coulter Inc.
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determ
Terminated		 KLIK023369
K926475
Jun 21, 2005Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
Terminated		 KLIK964721

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.