# K955794: Iga Immunoturbidimetric & Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Apr 5, 1996 after 105 days
- Product code: CZP (Iga, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 1, 2022 · Class II · Z-0362-2023: Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing 

Source page: https://510kreport.com/device/K955794
Methodology: https://510kreport.com/methodology