Data / Medical devices / Germany / Abbott Automation Solutions GmbH
Abbott Automation Solutions GmbH: FDA-registered device maker in Hamburg, Germany, 2 510(k) clearances
Abbott Automation Solutions GmbH is registered with the FDA (registration 3023268435) in Hamburg, Germany. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 5, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023268435
- Address
- Sachsenkamp 5, Hamburg, Germany, 20097
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- June 27, 2022
- Registered through
- 2027
- Brand names listed
- GLP systems Track (LN 04Z96-51)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Human Chorionic Gonadotropin | DHA | 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 5, 2023 | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| March 10, 2022 | K213486 | GLP systems Track | JGS | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of System, Test, Human Chorionic Gonadotropin
- All makers of Electrode, Ion Specific, Potassium
- All makers of Electrode, Ion-Specific, Chloride
- All makers of Electrode, Ion Specific, Sodium
Updated June 5, 2023. 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.