# K041643: Synchron Systems Phosphorus (PHS) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 18, 2004 after 62 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
Longest line of descent: 1 generation back to K883181 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883181: Synchron CX4/CX5 Clinical Chemistry Analyzer Reage, Beckman Instruments, Inc. (1988) Summary page 1.

## Indications for use
PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON Multi Calibrator, is intended for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or 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/K041643
Methodology: https://510kreport.com/methodology