Class Class II
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968)
Description
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL by Instrumentation Laboratory (IL) Co., an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251968
Clearance Date2025-07-24
Clearance TypeSpecial
Product CodeKQJ
Regulation Number864.7340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251968
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 Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K073367 | HEMOSIL FIBRINOGEN-C | Instrumentation Laboratory CO | 2007 |
Trace the full predicate network for K251968
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.