510(k) K220031 ยท GKZ Counter, Differential Cell
Alinity h-series System
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 4, 2023 |
| Received | Jan 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2025 | Abbott Laboratories Brand Name: Alinity hq Analyzer
Product Name: Alinity hq Analyzer
Model/Catalog Number: 09P68-01
Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US
Product Description: Alinity hq Analy Open, Classified |
GKZ | None listed |
| Aug 16, 2024 | Abbott Laboratories Alinity hq Analyzer, REF: 09P68-01 Open, Classified |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.