510(k) · Cleared
ClearedCell-Chex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · GJR Control, Red-Cell
Cleared on Mar 3, 2000 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 3, 2000
- Review
- 53 days
- Class
- Class II
- Product code
- GJR
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK000076 Cell-ChexStreck Laboratories, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK051706 IQ Body Fluids ControlStreck · 2005
- Descendant · 2 generations on · 5 of its ownK053362 Cell-Chex AutoStreck · 2006
- Descendant · 3 generations on · 2 of its ownK120744 XN Check BFStreck · 2012
- Descendant · 4 generations on · 1 of its ownK141957 XN Check BFStreck · 2014
- Descendant · cites it directly · 1 of its ownK101335 Cell-ChexStreck · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K051706IQ Body Fluids ControlStreck · 2005 · cites it directly6descendants
- K053362Cell-Chex AutoStreck · 2006 · 2 generations on5descendants
- K120744XN Check BFStreck · 2012 · 3 generations on2descendants
- K141957XN Check BFStreck · 2014 · 4 generations on1descendant
- K101335Cell-ChexStreck · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000076 | Cell-Chex | Streck Laboratories, Inc. | 2000 | — |
| +1 | K051706 | IQ Body Fluids Control | Streck | 2005 | — |
| +2 | K053362 | Cell-Chex Auto | Streck | 2006 | — |
| +3 | K120744 | XN Check BF | Streck | 2012 | — |
| +4 | K141957 | XN Check BF | Streck | 2014 | — |
| +1 | K101335 | Cell-Chex | Streck | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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 GJR? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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, K051706 (Streck, 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GJR devicesGJR Control, Red-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJR
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · GJR
Too few GJR 510(k)s in any year since 2007 to give a median.
Recalls per year · GJR
No recall names GJR since 2007.
Adverse event reports per year · GJR
No MAUDE report names GJR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000076: Cell-Chex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000076
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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