KEL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adhesive, Albumin-Based
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ATS MAYER'S ALBUMIN (K890022) | Alpha-Tec Systems, Inc. | 1989-01-10 |
| HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED (K881477) | Stat Path | 1988-04-18 |
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Every clearance here is in the API, with alerts when new ones post.