510(k) · Cleared
ClearedCD-Chex + RBC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · GGL Control, White-Cell
Cleared on May 24, 1996 as substantially equivalent to K920997 (Streck Laboratories, Inc., 1992) after an 80-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- May 24, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- GGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920997 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920997 CD-ChexStreck Laboratories, Inc. · 1992
- This deviceK960894 CD-Chex + RBCStreck Laboratories, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK051633 CD-Chex Plus BCStreck · 2005
- Descendant · 2 generations on · 0 of its ownK083926 CD4 CountStreck · 2009
- Descendant · cites it directly · 0 of its ownK993126 CD-Chex CD 34Streck Laboratories, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920997 | CD-Chex | Streck Laboratories, Inc. | 1992 | — |
| 0 (this device) | K960894 | CD-Chex + RBC | Streck Laboratories, Inc. | 1996 | — |
| +1 | K051633 | CD-Chex Plus BC | Streck | 2005 | — |
| +2 | K083926 | CD4 Count | Streck | 2009 | — |
| +1 | K993126 | CD-Chex CD 34 | Streck Laboratories, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 GGL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K920997 | CD-Chex Our OCR of the scanned summary read K920937, FDA’s number for Computerized Pupil (Trek Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CD-Chex”. | 1992 |
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?
How does its category compare?
All GGL devicesGGL Control, White-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGL
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GGL
Too few GGL 510(k)s in any year since 2007 to give a median.
Recalls per year · GGL
No recall names GGL since 2007.
Adverse event reports per year · GGL
1in 2023
MAUDE reports naming product code GGL, 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 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems
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/K960894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960894: CD-Chex + RBC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960894
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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