510(k) · Cleared
ClearedMouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/Rpe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako Corp. · GKZ Counter, Differential Cell
Cleared on Jun 24, 1997 after a 194-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 24, 1997
- Review
- 194 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964974 Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14…Dako Corp. · 1997
- Descendant · cites it directly · 0 of its ownK060423 Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and…Dakocytomation California, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060423Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and FluorospheresDakocytomation California, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14… | Dako Corp. | 1997 | — |
| +1 | K060423 | Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres | Dakocytomation California, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 GKZ? 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 GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · 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 |
|---|---|---|---|
| * | — | Becton Dickinson Simultest LeucoGATE Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060423 | Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres | 2006 | 0 |
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, K060423 (Dakocytomation California, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 (Anti-CD45/FITC, T29/33) and Monoclonal Mouse Anti-Human Monocyte, CD 14, RPE-Conjugated, Clone TUK4 (Anti-CD14/RPE. TUK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested…
Read the full statement (206 words)
Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 (Anti-CD45/FITC, T29/33) and Monoclonal Mouse Anti-Human Monocyte, CD 14, RPE-Conjugated, Clone TUK4 (Anti-CD14/RPE. TUK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenotyping of lymphocytes in peripheral blood.
Lymphocyte gating is assigned by selection of the upper and lower channel numbers to define the lymphocyte population and is a quality control function for flow cytometry. Gating verification is performed by identification of 99%1% of the cells as CD45"™* with CD14" as 2% or less of the cell population.
Note that this definition of “lymphocyte” does not give complete and unambiguous resolution from ail other cell types. When optimizing light scatter gates for lymphocytes, operator and/or software algorithms are minimizing the number of lymphocytes excluded while still maintaining acceptable levels of contaminating cell types. Lymphocyte gate purity may be calculated by determining the percentage of non-lymphocyte events within the gate. Most non-lymphocytes are CD14 positive. Because each flow cytometer has different operating characteristics, each laboratory must determine its optimal operating procedure.
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/K964974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964974: Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/Rpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964974
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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