510(k) K150877 ยท GKP Instrument, Coagulation, Automated
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 13, 2015 |
| Received | Apr 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150877
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2023 | Instrumentation Laboratory ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis Open, Classified |
GKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.