Class Class II
CRYOcheck Chromogenic Factor VIII (K251440)
Description
CRYOcheck Chromogenic Factor VIII by Precision Biologic, Inc., an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251440
Clearance Date2025-08-25
Clearance TypeTraditional
Product CodeGGP
Regulation Number864.7290
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251440
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. CRYOcheck Chromogenic Factor VIII (K251440) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | 2020 |
Trace the full predicate network for K251440
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.