MLE — Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control Class II
FDA Device Classification
Classification Details
- Product Code
- MLE
- Device Class
- Class II
- Regulation Number
- 866.5110
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K010558 | inova diagnostics | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | April 3, 2001 |
| K991942 | cogent diagnotics | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | August 24, 1999 |
| K951206 | elias u.s.a | VARELISA PARIETAL CELL ANTIBODIES | April 17, 1995 |