# K983503: Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog Number 1730347

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 1, 1998 after 56 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) Roche Diagnostics, Boehringer Mannheim Phosphorus (inorganic) test system: named in the summary without a submission number

## Indications for use
The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus reagent is intended for use for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1580, a Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Source page: https://510kreport.com/device/K983503
Methodology: https://510kreport.com/methodology