Biotech, Inc.
FDA Regulatory Profile
Biotech, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Jun 4, 2026 · NAI
- Latest 510(k)
- Jan 9, 2014
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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 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jun 4, 2026 | Alpharetta, GA | Devices | No Action Indicated (NAI) | 3010781586 |
| Feb 28, 2018 | Alpharetta, GA | Devices | No Action Indicated (NAI) | 3010781586 |
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.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K122982 | CRYOLOCK | Jan 9, 2014 |