# K851202: Gilford Tri-Level Assayed Immunology Control

- Pathway: 510(k) (Traditional)
- Applicant: Gilford
- Decided: Apr 29, 1985 after 34 days
- Product code: DAK (Complement C1q, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K984045: RF Control for Immunoturbidimetric Assays (1999), 0 descendants of its own
- K983130: Liquid Immunology Controls for Immunoturbidimetric Assays (1998), 0 descendants of its own
- K983241: Aso/CRP/RF Controls for Immunoturbidimetric Assays (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K851202
Methodology: https://510kreport.com/methodology