510(k) K242127 ยท GKP Instrument, Coagulation, Automated
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
| Applicant | Instrumentation Laboratory (IL) Co., Bedford MA, US |
| Decision | Substantially Equivalent, Aug 16, 2024 |
| Received | Jul 19, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242127
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.