# K972337: Dclare Immunodip Stickfor Microalbuminuria

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Aug 8, 1997 after 46 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K994035: Immunodip Urinary Albumin Screen, Model 790-01, 790-15 (2000), 0 descendants of its own

## Indications for use
For the rapid, semi—quantitative determination of microalbuminuria. For In Vitro diagnostic use. For early detection and monitoring of the course of incipient nephropathy in diabetics and early detection and monitoring of hypertemsion. (8-12)

Source page: https://510kreport.com/device/K972337
Methodology: https://510kreport.com/methodology