# K860894: Behring Nephelometer System

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Apr 15, 1986 after 36 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 17 cite it directly.
0 of 45 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
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) (2005), 10 descendants of its own
- K053072: N Antisera to Human ALPHA1-Antitrypsin (2006), 8 descendants of its own
- K061338: Dimension Vista Iga Flex Reagent Cartridge Assay (2006), 7 descendants of its own
- K962523: N Latex CRP Mono Reagent (1996), 7 descendants of its own
- K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H (2007), 6 descendants of its own

Source page: https://510kreport.com/device/K860894
Methodology: https://510kreport.com/methodology