510(k) · Cleared
ClearedLiquichek Rheumatoid Factor Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · DHR System, Test, Rheumatoid Factor
Cleared on Jun 4, 1996 as substantially equivalent to K923578 (Bio-Rad, 1992) after an 85-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jun 4, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- DHR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923578 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923578 Liquichek Rheumatoid Factor ControlBio-Rad · 1992
- This deviceK960987 Liquichek Rheumatoid Factor ControlBio-Rad · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923578 | Liquichek Rheumatoid Factor Control | Bio-Rad | 1992 | — |
| 0 (this device) | K960987 | Liquichek Rheumatoid Factor Control | Bio-Rad | 1996 | — |
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 DHR? 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 |
|---|---|---|---|
| * | K923578 | Liquichek Rheumatoid Factor ControlSummary page 1…Name Class Il CFR 866.5775, Rheumatoid Factor Immunological Test System 82DHR Devices to Which Substantial Equivalence is Claimed Liquichek Rheumatoid Factor Control K923578 Statement of Intended Use Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monito… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHR
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · DHR
Too few DHR 510(k)s in any year since 2007 to give a median.
Recalls per year · DHR
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHR
2in 2025
MAUDE reports naming product code DHR, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 19 |
| 2011 | 1 | — | 3 | 400 |
| 2012 | 0 | — | 2 | 91 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 2 | 1 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s rheumatoid factor testing methodologies.
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/K960987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960987: Liquichek Rheumatoid Factor Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960987
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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