# K974605: Randox Inorganic Phosphorous

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 9, 1998 after 30 days
- Product code: CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus)
- Device class: 1
- Regulation: 21 CFR 862.1580
- 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 Randox Laboratories Limited Inorganic Phosphorous Test Kit is an in vitro diagnostic reagent for the quantitative determination of inorganic phosphorous in serum. The method is based on the interaction of inorganic phosphorous with ammonium-molybdate in the presence of sulphuric acid to form a phosphomolybdate complex which is measured at 340nm. Measurements of inorganic phosphorous are used in the diagnosis and treatment of various disorders including, renal failure, hyper- and hypoparathyroidism and vitamin D deficiency. This test kit must be used by suitably qualified laboratory personnel, under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K974605
Methodology: https://510kreport.com/methodology