# K823884: Paragon Immunoelectrophoresis Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 7, 1983 after 70 days
- Product code: CFF (Immunoelectrophoretic, 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K993547: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb (2000), 2 descendants of its own
- K130122: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter (2014), 0 descendants of its own
- K050119: Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit (2005), 0 descendants of its own
- K032014: N Latex Igm (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K823884
Methodology: https://510kreport.com/methodology