# K951550: CMV Brite Antigenemia Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biotest Diagnostics Corp.
- Decided: Jan 30, 1996 after 301 days
- Product code: LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K991650: CMV Brite Turbo Kit (1999), 0 descendants of its own
- K982311: Bartels Cinakit CMV Antigenemia (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K951550
Methodology: https://510kreport.com/methodology