510(k) · Cleared
ClearedPanbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panbio, Inc. · GRY Antigens, All, Leptospira Spp.
Cleared on Nov 22, 2000 after a 142-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Nov 22, 2000
- Review
- 142 days
- Class
- Class II
- Product code
- GRY
- 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 GRY? 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 GRY devicesGRY Antigens, All, Leptospira Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GRY
FDA has decided no GRY device since 2007.
Median 510(k) review, days · GRY
Too few GRY 510(k)s in any year since 2007 to give a median.
Recalls per year · GRY
No recall names GRY since 2007.
Adverse event reports per year · GRY
No MAUDE report names GRY 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 | 0 | — | 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/K002024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002024: Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002024
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026