# P880016: Oncor B/T Gene Rearrangement Test

- Pathway: PMA
- Applicant: Oncor, Inc.
- Decided: Oct 10, 1989 after 588 days
- Product code: MAM (Dna-Probe, B And T Lymphocyte)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P880016
Methodology: https://510kreport.com/methodology