510(k) K231031 ยท GKP Instrument, Coagulation, Automated
ACL TOP Family 70 Series
| Applicant | Instrumentation Laboratory Company, Bedford MA, US |
| Decision | Substantially Equivalent, Jun 21, 2023 |
| Received | Apr 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231031
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.