# K973189: Retinol Binding Protein RBP Rid Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Sep 29, 1997 after 35 days
- Product code: CZS (Retinol-Binding Protein, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5765
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The kit is for quantitating retinol binding protein in human urine as an aid in diagnosing kidney disease.

Source page: https://510kreport.com/device/K973189
Methodology: https://510kreport.com/methodology