# K981769: Hichem Phosphorus Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Elan Pharma, Inc.
- Decided: Jun 29, 1998 after 41 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. The FDA summary names its predicate without a number.
- (no number) BMD® Phosphorus Reagent: named in the summary without a submission number
- (no number) Beckman® SYNCHRON® Systems Phosphorus Reagent: named in the summary without a submission number

## Indications for use
HiChem Phosphorus Reagent is intended for the quantitative determination of inorganic phosphorus in serum, plasma and urine for the diagnosis and treatment of various disorders including parathyroid gland and kidney diseases, and vitamin D imbalance. This reagent is intended to be used in a professional setting or by trained personnel and is not intended for home use.

Source page: https://510kreport.com/device/K981769
Methodology: https://510kreport.com/methodology