# K831342: Coat-a-Count NO-Extraction Testosterone

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 2, 1983 after 38 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K023091: ST Aia-Pack Testosterone Assay (2002), 0 descendants of its own
- K955102: Biodata Testosterone Maia Kit (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K831342
Methodology: https://510kreport.com/methodology