510(k) · Cleared
ClearedHemagen C-Reactive Protein Kit (Eia Method)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Oct 3, 1994 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 3, 1994
- Review
- 31 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK944288 Hemagen C-Reactive Protein Kit (Eia Method)Hemagen Diagnostics, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK984132 Immulite C-Reactive Protein, Models LKC1, LKC5Diagnostic Products Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK990886 Immulite C-Reactive Protein, Model LKCR1, LKCR5Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 0 of its ownK960324 Hemagen CRP 150 Kit (Eia Method)Hemagen Diagnostics, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K984132Immulite C-Reactive Protein, Models LKC1, LKC5Diagnostic Products Corp. · 1999 · cites it directly1descendant
- K990886Immulite C-Reactive Protein, Model LKCR1, LKCR5Diagnostic Products Corp. · 1999 · 2 generations on0descendants
- K960324Hemagen CRP 150 Kit (Eia Method)Hemagen Diagnostics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944288 | Hemagen C-Reactive Protein Kit (Eia Method) | Hemagen Diagnostics, Inc. | 1994 | — |
| +1 | K984132 | Immulite C-Reactive Protein, Models LKC1, LKC5 | Diagnostic Products Corp. | 1999 | — |
| +2 | K990886 | Immulite C-Reactive Protein, Model LKCR1, LKCR5 | Diagnostic Products Corp. | 1999 | — |
| +1 | K960324 | Hemagen CRP 150 Kit (Eia Method) | Hemagen Diagnostics, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K984132 (Diagnostic Products Corp., 1999) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K944288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944288: Hemagen C-Reactive Protein Kit (Eia Method).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944288
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026