# K951635: Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 15, 1995 after 38 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K963974: Image-Immunochemistry System Urine Immunoglobulin (1997), 2 descendants of its own
- K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC (2009), 1 descendant of its own
- K973928: Beckman Urine Protein Calibrator (Ucal) (1997), 1 descendant of its own
- K233663: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (2023), 0 descendants of its own
- K081161: Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K951635
Methodology: https://510kreport.com/methodology