# K850054: Rianen Angiotensin I Radioimmunoassay KI

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Mar 29, 1985 after 80 days
- Product code: CIB (Radioimmunoassay, Angiotensin I And Renin)
- Device class: 2
- Regulation: 21 CFR 862.1085
- Recalls of this device: 2 (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
- Jul 28, 2003 · Not classified · Z-1207-03: Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
- Jul 28, 2003 · Not classified · Z-1206-03: Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples

Source page: https://510kreport.com/device/K850054
Methodology: https://510kreport.com/methodology