# K981871: C-Reactive Protein Elisa, Model Number DSL-10-42100

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Nov 9, 1998 after 165 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K544288: CRP 150 Kit. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K981871
Methodology: https://510kreport.com/methodology