Data / Medical devices / Singapore / Abbott Laboratories (Singapore) Private Limited
Abbott Laboratories (Singapore) Private Limited: FDA-registered device maker in - Central Singapore, Singapore, 4 510(k) clearances
Abbott Laboratories (Singapore) Private Limited is registered with the FDA (registration 3006412379) in - Central Singapore, Singapore. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 20, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006412379
- Address
- 3 Fraser Street #23-28 DUO Tower, - Central Singapore, Singapore, 189352
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Exporter to the US
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- ALINITY HQ ANALYZER (09P68-01), ALINITY HS SLIDE MAKER STAINER MODULE (09P69-01), Alinity hq (LN 09P68-02), Alinity hq Processing Module (LN 09P6801), Alinity hs (09P69-02), Alinity hs Processing Module (LN 09P6901), CELL-DYN Ruby System (LN 08H67-01, 08H67-03), CELL-DYN Sapphire System (LN 08H00-01, 08H00-03)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Exporter to the US | accessdata.fda.gov |
| Slide Stainer, Automated | KPA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| February 20, 2025 | K243283 | Alinity h-series System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 4, 2023 | K220031 | Alinity h-series System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 10, 2006 | K061667 | CELL-DYN RUBY SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 21, 2005 | K051215 | CELL-DYN SAPPHIRE SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Compare with other makers
Updated February 20, 2025. 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.