Company
Tecan US, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
19recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2019 | Tecan US, Inc. Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. Terminated |
JQW | None listed |
| Jul 23, 2018 | Tecan US, Inc. Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher Terminated |
JQW | None listed |
| Jan 12, 2018 | Tecan US, Inc. Cortisol Saliva Luminescence Immunoassay
The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva Terminated |
NHG | K150528 |
| Aug 25, 2016 | Tecan US, Inc. Hydroflex ELISA
The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain info Terminated |
LXG | None listed |
| Aug 25, 2016 | Tecan US, Inc. Tecan Infinite M1000 PRO
The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications Terminated |
JJQ | None listed |
| Aug 25, 2016 | Tecan US, Inc. Tecan Infinite M1000
The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and rese Terminated |
JJQ | None listed |
| Aug 25, 2016 | Tecan US, Inc. Infinite 200 PRO
The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate appli Terminated |
JJQ | None listed |
| Aug 25, 2016 | Tecan US, Inc. Tecan Infinite 200.
The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in Terminated |
JJQ | None listed |
| Aug 25, 2016 | Tecan US, Inc. SUNRISE instrument.
The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primaril Terminated |
JJQ | None listed |
| Aug 25, 2016 | Tecan US, Inc. Infinite F50 instrument.
The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used pri Terminated |
JJQ | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite 200 in vitro diagnostic.
Product Usage:
The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majorit Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite 200 PRO in vitro diagnostic.
Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite M1000 in vitro diagnostic.
Product Usage:
The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite M1000 PRO in vitro diagnostic.
Product Usage:
The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority o Terminated |
KHO | None listed |
| Jul 2, 2015 | Tecan US, Inc. Infinite F500, in vitro diagnostic.
Product Usage:
The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majo Terminated |
KHO | None listed |
| Jan 15, 2015 | Tecan US, Inc. Infinite 200PRO
The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications a Terminated |
KHO | None listed |
| Jan 15, 2015 | Tecan US, Inc. Infinite 200
The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and Terminated |
KHO | None listed |
| Oct 29, 2014 | Tecan US, Inc. Freedom EVO-2 100 Base Unit, with Air LiHa Arms
The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose Terminated |
JQW | None listed |
| Jun 19, 2013 | Tecan US, Inc. Tecan Freedom EVO with Touch Tools Suite Version 3.0
The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an o Terminated |
JQW | None listed |