510(k) · Cleared
ClearedAntibody Assay for Detec. of Resp. Syncytial Virus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microscan Div. Baxter Healthcare Corp. · LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Cleared on Jun 26, 1987 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Jun 26, 1987
- Review
- 91 days
- Class
- Class I
- Product code
- LKT
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 LKT? 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?
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.
How does its category compare?
All LKT devicesLKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKT
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LKT
Too few LKT 510(k)s in any year since 2007 to give a median.
Recalls per year · LKT
No recall names LKT since 2007.
Adverse event reports per year · LKT
No MAUDE report names LKT 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/K871230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K871230: Antibody Assay for Detec. of Resp. Syncytial Virus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871230
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026