Ai DE Diagnostic Co., Ltd.
FDA Regulatory Profile
Ai DE Diagnostic Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- May 30, 2024 · VAI
- Latest 510(k)
- Jul 23, 2007
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3008760472 | Qingdao, China | 2 | May 30, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K062703 | ONE STEP HCG PREGNANCY TEST | Jul 23, 2007 |