MLE
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5110
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (K010558) | Inova Diagnostics, Inc. | 2001-04-03 |
| AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA (K991942) | Cogent Diagnotics , Ltd. | 1999-08-24 |
| VARELISA PARIETAL CELL ANTIBODIES (K951206) | Elias U.S.A., Inc. | 1995-04-17 |
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Every clearance here is in the API, with alerts when new ones post.