510(k) Report

FDA product code · Immunology

System, Test, C-Reactive Protein, Rhodamine

DCHClass II21 CFR 866.5270510(k) required1 decision since 19960 recalls

1 FDA decision since 1996. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of DCH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · DCH

FDA has decided no DCH device since 2007.

Median 510(k) review, days · DCH

Too few DCH 510(k)s in any year since 2007 to give a median.

Recalls per year · DCH

No recall names DCH since 2007.

Adverse event reports per year · DCH

No MAUDE report names DCH since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DCH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DCH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which DCH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K964687N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 19962generations

What has FDA decided in DCH lately?

  • K964687N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996

The one DCH decision →

Related product codes

Other codes under 21 CFR 866.5270.

DCK C-Reactive Protein, Antigen, Antiserum, And…NQD Cardiac C-Reactive Protein, Antigen…DCN System, Test, C-Reactive Protein