LEA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Preservative, Cytological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2002: 3 · 2007: 5 · 2008: 4 · 2009: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TIF FECAL TEST (K873594) | Devetec, Inc. | 1987-09-29 |
| CYTOLOGY FIXATIVE (K770592) | Surgipath Medical Industries, Inc. | 1977-05-20 |
| PAP-TRAY II (CATALOG #C600-2) (K761001) | Lerner Laboratories, Inc. | 1976-12-06 |
| PAP-TRAY I (CATALOG #C600-1) (K761000) | Lerner Laboratories, Inc. | 1976-12-06 |
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Every clearance here is in the API, with alerts when new ones post.