# K954755: Coat-a-Count Direct Androstenedione

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Nov 29, 1995 after 44 days
- Product code: CIZ (Radioimmunoassay, Androstenedione)
- Device class: 1
- Regulation: 21 CFR 862.1075
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 9, 2014 · Class II · Z-2058-2014: The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

Source page: https://510kreport.com/device/K954755
Methodology: https://510kreport.com/methodology