510(k) · Cleared
ClearedNRBC-Chex for LH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · GJR Control, Red-Cell
Cleared on Feb 9, 2006 as substantially equivalent to K000945 (Streck Laboratories, Inc., 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Feb 9, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- GJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000945 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K080016NRBC-Chex for AdviaStreck · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000945 | Para 12 Plus Retics | Streck Laboratories, Inc. | 2000 | — |
| 0 (this device) | K060083 | NRBC-Chex for LH | Streck | 2006 | — |
| +1 | K080016 | NRBC-Chex for Advia | Streck | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K000945 | Para 12 Plus ReticsSummary page 1…Assayed Hematology Control Classification Name: Nucleated Cell and Red Blood Cell Control (864.8625) Predicate Device: Para 12 Plus Retics (K000945) Manufactured by Streck Description: nRBC-Chex for LH is stabilized suspension of human and animal blood, in a solution contain… | 2000 |
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 |
|---|---|---|---|
| K080016 | NRBC-Chex for Advia | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K080016 (Streck, 2008) has gone furthest, with 0 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 | — |
What is it indicated for?
nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060083: NRBC-Chex for LH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060083
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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