Class Class II
HemosIL CL HIT-IgG(PF4-H) (K243374)
Description
HemosIL CL HIT-IgG(PF4-H) by Instrumentation Laboratory (IL) Co., an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243374
Clearance Date2025-01-28
Clearance TypeTraditional
Product CodeLCO
Regulation Number864.7695
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243374
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. HemosIL CL HIT-IgG(PF4-H) (K243374) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017 |
| K083518 | ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIM... | Instrumentation Laboratory CO | 2009 |
Trace the full predicate network for K243374
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.