# K896271: Quantex RF Plus (Latex, Buffer Standard, Control)

- Pathway: 510(k) (Traditional)
- Applicant: Biokit USA, Inc.
- Decided: Nov 8, 1989 after 9 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K971777: Quantex Aso-CRP-RF Control (1997), 1 descendant of its own
- K984437: Quantex Aso-CRP-RP Control II (1999), 0 descendants of its own
- K973464: Quantex RF Plus (Latex, Buffer, Standard, Control) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K896271
Methodology: https://510kreport.com/methodology