510(k) · Cleared

Cleared

N Latex CRP Mono Reagent

K964687510(k) TraditionalCleared Dec 16, 199690-day reviewClass II21 CFR 866.5270

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

Behring Diagnostics, Inc. · DCH System, Test, C-Reactive Protein, Rhodamine

Cleared on Dec 16, 1996 as substantially equivalent to K962523 (Behring Diagnostics, Inc., 1996) after a 90-day review. Its family tree reaches back 2 generations to 1986.

Decided: Dec 16, 1996
Review: 90 days
Class: Class II
Product code: DCH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K860894 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
1 generation backK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
This deviceK964687 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K860894	Behring Nephelometer System	Behring Diagnostics, Inc.	1986	—
−1	K962523	N Latex CRP Mono Reagent	Behring Diagnostics, Inc.	1996	—
0 (this device)	K964687	N Latex CRP Mono Reagent	Behring Diagnostics, Inc.	1996	—

FIG. 1 — Lineage of K964687, 1986–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DCH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962523	N Latex CRP Mono Reagent Summary page 1 …otein (CRP) Class Il (866.5270). 3. Identification of the legally marketed device to which the submitter claims equivalence: The Behringwerke N Latex CRP mono Reagent (K962523) 4. Proposed Device Description: The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended…	Behring Diagnostics, Inc.	1996	—

Also cleared against K962523: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 10.2 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K962523.

How does its category compare?

All DCH devices

DCH System, Test, C-Reactive Protein, Rhodamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The proposed test reagent (N Latex CRP._mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964687 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964687: N Latex CRP Mono Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964687

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026