Data / Medical devices / Finland / Thermo Fisher Scientific OY
Thermo Fisher Scientific OY: FDA-registered device maker in VANTAA Uusimaa, Finland, 1 510(k) clearance
Thermo Fisher Scientific OY is registered with the FDA (registration 9610942) in VANTAA Uusimaa, Finland. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9610942
- FEI number
- 3007262384
- Address
- 2 Ratastie, VANTAA Uusimaa, Finland, 01620
- Owner or operator
- THERMO FISHER SCIENTIFIC INC. (2182773)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 13, 2001
- Registered through
- 2026
- Brand names listed
- ALIQUOTER AND LABELLER, BUFFER, BULK INTERFACE MODULE, CENTRIFUGE FLEX MODULE, CENTRIFUGE MODULE, CONVEYOR 1200 MM, CONVEYOR 1500 MM, CONVEYOR 1800 MM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cuvette, Thermostated | JRI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Detergent | JCB | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Hexokinase, Glucose | CFR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 2011 | K110035 | INDIKO | JJE | Substantially Equivalent | Thermofisher Scientific OY | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 1, 2021 | 87309 | Class II | Terminated | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 | Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D | accessdata.fda.gov |
Compare with other makers
- All makers of Detergent
- All makers of Cuvette, Thermostated
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Hexokinase, Glucose
Updated June 28, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.