510(k) · Cleared
ClearedMouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/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 14, 1996 as substantially equivalent to K945692 (Dako Corp., 1995) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 14, 1996
- Review
- 60 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943284 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK943284 Monoclonal Mouse Anti-Human B-CellDako Corp. · 1994
- This deviceK961435 Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19…Dako Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943284 | Monoclonal Mouse Anti-Human B-Cell | Dako Corp. | 1994 | — |
| 0 (this device) | K961435 | Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/Rpe | Dako Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K945692 | Monoclonal Mouse Anti-Human T-Cell, CD2, Clone MT910 Fitc-Conjugated, (Anti-CD2,Fitc…Summary page 1…atology and Pathology devices panel, Division of Clinical Laboratory Devices. GKZ DAKO Monoclonal Mouse Anti-Human T-cell, CD2/FITC, MT910 (DAKO Code Number FO767, FDA K945692) and DAKO Monoclonal Mouse Anti-Human B-cell, CD19/RPE, Clone HD37 (DAKO Code Number RO808, FDA K943284) Purified mouse anti-h… | 1995 |
| * | K943284 | Monoclonal Mouse Anti-Human B-CellSummary page 1…Anti-Human T-cell, CD2/FITC, MT910 (DAKO Code Number FO767, FDA K945692) and DAKO Monoclonal Mouse Anti-Human B-cell, CD19/RPE, Clone HD37 (DAKO Code Number RO808, FDA K943284) Purified mouse anti-human CD2, Clone MT910, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-h… | 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?
- None of the 2 ancestors has a recall.
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?
Mouse Anti-Human T-cell, CD2/FITC, MT910 + Mouse Anti-Human B-cell, CD19/RPE, HD37 (DAKO Anti-CD2/FITC and Anti-CD19/RPE) has been developed for use in flow cytometry for the analysis of CD2" T-cells and CD19" B-cells. This reagent allows simultaneous detection and guantification of T- and B-cells in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monocional antibody (MAD) combinations for routine immunophenotyping of lymphocytes in peripheral bicod using flow cytometry.
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/K961435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961435: Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/Rpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961435
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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