# K011128: Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample Diluent)

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Sep 6, 2001 after 146 days
- Product code: CIB (Radioimmunoassay, Angiotensin I And Renin)
- Device class: 2
- Regulation: 21 CFR 862.1085
- Recalls of this device: none
- 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.

Source page: https://510kreport.com/device/K011128
Methodology: https://510kreport.com/methodology