# K030772: Rdi Extended Range CRP Calibrator Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Reference Diagnostics, Inc.
- Decided: Apr 11, 2003 after 31 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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
For in vitro diagnostic use only. The RDI Extended Range CRP Calibrator Set is intended for medical purposes for use with the RDI Extended Range hsCRP Kit, to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.

Source page: https://510kreport.com/device/K030772
Methodology: https://510kreport.com/methodology