INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315)
Description
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) by Siemens Healthcare Diagnostics Products GmbH, an FDA 510(k) cleared hematology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240315
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023 |
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 |
| K172286 | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Produ... | 2017 |
| K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL... | Instrumentation Laboratory CO | 2016 |
| K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS;... | Instrumentation Laboratory CO | 2015 |
Trace the full predicate network for K240315
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.