# K831178: Coat-a-Count NO-Extraction Aldosterone

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 27, 1983 after 46 days
- Product code: CJM (Radioimmunoassay, Aldosterone)
- Device class: 2
- Regulation: 21 CFR 862.1045
- 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
- K142994: IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (2015), 0 descendants of its own
- K130321: Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers (2013), 0 descendants of its own
- K032188: Nichols Advantage Aldosterone Assay (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K831178
Methodology: https://510kreport.com/methodology