# K943997: Behring Nephelometer II

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Oct 3, 1994 after 48 days
- Product code: DEW (Igg, Antigen, Antiserum, Control)
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050113: Tina-Quant Igg Gen.2 (2005), 4 descendants of its own
- K073490: Olympus Igg Reagent (2008), 3 descendants of its own
- K162208: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (2017), 1 descendant of its own
- K221114: Immunoglobulin G (IgG) (2023), 0 descendants of its own
- K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K943997
Methodology: https://510kreport.com/methodology