Ixensor Co, Ltd. FDA Record
- No warning letters matched by name
Ixensor Co, Ltd. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ixensor Co, Ltd." is on file.
- Latest 510(k)
- Oct 29, 2019
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 3 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Oct 29, 2019 |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Apr 12, 2019 |
| K163087 | PixoTest Blood Glucose Monitoring System | Nov 2, 2017 |
Ixensor Co, Ltd. and the FDA: common questions
Has Ixensor Co, Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Ixensor Co, Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Ixensor Co, Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Ixensor Co, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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