510(k) · Cleared
ClearedN Latex CRP Mono Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Jul 10, 1996 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 41-day review. Its family tree reaches back 1 generation to 1986. 7 later devices descend from it.
- Decided
- Jul 10, 1996
- Review
- 41 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860894 (1986). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- This deviceK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK981638 Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 1 of its ownK050836 CRP Diagnostic AssaySentinel Ch. Srl · 2005
- Descendant · 3 generations on · 0 of its ownK192118 CRP VarioSENTINEL CH. SpA · 2019
- Descendant · 2 generations on · 0 of its ownK022690 Paros CRPHoriba, Ltd. · 2002
- Descendant · 2 generations on · 0 of its ownK990704 Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc. · 1999
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K981638Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc. · 1998 · cites it directly4descendants
- K050836CRP Diagnostic AssaySentinel Ch. Srl · 2005 · 2 generations on1descendant
- K192118CRP VarioSENTINEL CH. SpA · 2019 · 3 generations on0descendants
- K022690Paros CRPHoriba, Ltd. · 2002 · 2 generations on0descendants
- K990704Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| 0 (this device) | K962523 | N Latex CRP Mono Reagent | Behring Diagnostics, Inc. | 1996 | — |
| +1 | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) Reagent | Beckman Coulter, Inc. | 1998 | 1 |
| +2 | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
| +3 | K192118 | CRP Vario | SENTINEL CH. SpA | 2019 | — |
| +2 | K022690 | Paros CRP | Horiba, Ltd. | 2002 | — |
| +2 | K990704 | Array 360 System C-Reactive Protein (CRP Mpe) Reagent | Beckman Coulter, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
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 DCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DCK device
- #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K860894 | Behring Nephelometer SystemSummary page 1…C-reactive protein (CRP) Class Il (866.5270). 3. Identification of the legally marketed device to which the submitter claims equivalence: The Behringwerke N Latex CRP (K860894) 4, Proposed Device Description: The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intende… | 1986 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DCK devicesDCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DCK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DCK
Too few DCK 510(k)s in any year since 2007 to give a median.
Recalls per year · DCK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCK
1in 2021
MAUDE reports naming product code DCK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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.
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/K962523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962523: N Latex CRP Mono Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962523
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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