# K833892: Coatest Factor Viii

- Pathway: 510(k) (Traditional)
- Applicant: Kabivitrum, Inc.
- Decided: Jan 30, 1984 after 82 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042576: Coatest SP Fviii (2004), 2 descendants of its own
- K193204: Cryocheck Chromogenic Factor VIII (2020), 1 descendant of its own
- K981038: Coamatic Factor Viii (1998), 1 descendant of its own
- K251440: CRYOcheck Chromogenic Factor VIII (2025), 0 descendants of its own
- K052825: Visulize Factor Viii Antigen Kit, Model Fviii-AG (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K833892
Methodology: https://510kreport.com/methodology