# K952309: N Latex Iga

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jun 20, 1995 after 34 days
- Product code: CZP (Iga, 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.
4 later devices descend from it; 1 cites 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993549: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr (2000), 3 descendants of its own
- K183151: Optilite IgA CSF Kit (2019), 0 descendants of its own
- K060130: Immage Systems Low Concentration Immunoglobulin a Reagent (2006), 0 descendants of its own
- K024038: N Latex Iga (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K952309
Methodology: https://510kreport.com/methodology