510(k) · Cleared
ClearedHemagen CRP 150 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 Mar 12, 1996 as substantially equivalent to K944288 (Hemagen Diagnostics, Inc., 1994) after a 49-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 12, 1996
- Review
- 49 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944288 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944288 Hemagen C-Reactive Protein Kit (Eia Method)Hemagen Diagnostics, Inc. · 1994
- This deviceK960324 Hemagen CRP 150 Kit (Eia Method)Hemagen Diagnostics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944288 | Hemagen C-Reactive Protein Kit (Eia Method) | Hemagen Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K960324 | Hemagen CRP 150 Kit (Eia Method) | Hemagen Diagnostics, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K944288 | Hemagen C-Reactive Protein Kit (Eia Method)Summary page 1…ification Name: C-reactive protein immunological test system (per 21 CFR 866.5270) Predicate Device Hemagen ® C-Reactive Protein Kit (EIA method) Reference Docket No: K 944288 Page 1 6.(A) 510(k) Summary Hemagen ® CRP 150 Kit Description of Device An enzyme-linked immunosorbent assay… | 1994 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K944288.
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?
This kit has been designed for the measurement of C-reactive protein in human serum and plasma. When used according to instructions, the kit is useful in measuring the acute phase responses in humans to infection, tissue damage and various inflammatory conditions.
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/K960324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960324: Hemagen CRP 150 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/K960324
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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