# K973692: Ubi Magiwel C-Reactive Protein (CRP) Quantitative

- Pathway: 510(k) (Traditional)
- Applicant: United Biotech, Inc.
- Decided: Feb 9, 1998 after 136 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- 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 UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test Kit provides quantitative measurement of CRP level in human serum to ald in the evaluation of the amount of injury to body tlssues (for Professional use only)

Source page: https://510kreport.com/device/K973692
Methodology: https://510kreport.com/methodology