510(k) K243283 ยท GKZ Counter, Differential Cell
Alinity h-series System
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Feb 20, 2025 |
| Received | Oct 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243283
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.