Tecan U.S., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Tecan U.S., Ltd.” (first 1986, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 7 | 7 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| JRA | Microtitrator, For Clinical Use | 1 | 1 |
| KPA | Slide Stainer, Automated | 1 | 1 |
Review panels
- Clinical Chemistry (9)
- Pathology (1)
Most recent Tecan U.S., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963268 | GENESIS RMP | JRA | 1997-03-18 | 210 |
| K953345 | GENESIS | JQW | 1995-11-21 | 132 |
| K944556 | 4 CHANNEL DISPENSER | JQW | 1994-10-25 | 39 |
| K942655 | 4 CHANNEL DISPENSER | JQW | 1994-09-02 | 88 |
| K933996 | PROFIBLOT | KPA | 1994-01-28 | 164 |
| K915492 | RSP MEGA SAMPLE PROCESSOR | JQW | 1992-02-21 | 79 |
| K912036 | ROBOTIC SAMPLE PROCESSOR | JQW | 1991-07-26 | 79 |
| K910740 | SLT MICROPLATE WASHER | JJQ | 1991-03-27 | 34 |
| K894126 | ROBOTIC SAMPLE PROCESSOR | JQW | 1989-08-15 | 64 |
| K854406 | TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 | JQW | 1986-02-10 | 101 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2005-04-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tecan U.S., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Tecan U.S., Ltd.” (first 1986, latest 1997), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tecan U.S., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tecan U.S., Ltd. is 84 days.
Which FDA product codes appear under Tecan U.S., Ltd.?
The most frequent FDA product codes under this applicant name are JQW (Station, Pipetting And Diluting, For Clinical Use, 7); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 1); JRA (Microtitrator, For Clinical Use, 1).
Next steps
- See all 10 Tecan U.S., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JQW, Tecan U.S., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.