# K844423: Coat-a-Count Free Testosterone Kit & Components

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Feb 27, 1985 after 104 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- 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
- K030730: Free Testosterone Enzymeimmunoassay (Eia) Kit (2003), 2 descendants of its own
- K181017: Free Testosterone AccuBind ELISA Test System (2018), 1 descendant of its own
- K240865: IDS-iSYS Free Testosterone (2024), 0 descendants of its own
- K022533: Fastpack Testosterone Calibrator (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K844423
Methodology: https://510kreport.com/methodology