Panels › Clinical Chemistry › Product code CEC · Class 2
Radioimmunoassay, Free Thyroxine
Regulation 862.1695
0510(k)s in 12 months (92 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in CEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 8 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 8 | 0 |
| Siemens Healthcare Diagnostics | 5 | 2 |
| Amersham Corp. | 5 | 0 |
| Beckman Coulter, Inc. | 1 | 4 |
| Abbott Laboratories HPD/ADD | 0 | 3 |
| Corning Medical & Scientific | 3 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Roche Diagnostics | 3 | 0 |
| Advanced Magnetics, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 600, UniCel DxI 8 Terminated |
CEC | K982250 |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Free T4 Reagent Kit, List Number 07P7030 Terminated |
CEC | K173122 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Free Thyroxine (FT4L) Flex reagent cartridge Terminated |
CEC | K140842 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK FT4; Part Number: 025268
Assay, Thyroid Terminated |
CEC | K913493 |
| May 9, 2017 | Beckman Coulter Inc. Access System-Free T4 Assay, B01902E, Catalog No. 33880 Terminated |
CEC | K982250 |
| Dec 19, 2013 | Qualigen Inc FastPack Free T4 Immunoassay
Chemilunescence assay for the determination of Free T4
The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determinati Terminated |
CEC | K030329 |
| Apr 11, 2011 | Beckman Coulter Inc. Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769
The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxi Terminated |
CEC | K982250 |
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. Terminated |
CEC | K073604 |
| Oct 1, 2010 | Beckman Coulter Inc. Access Immunoassay Systems Free T4, Part Number: 33880 Terminated |
CEC | K982250 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K983417 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K983417 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K902834 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K934544 |
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