FDA Product Code
FDA Product Code MLE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5110
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K010558 | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | Inova Diagnostics, Inc. | 2001-04-03 | Traditional | PDF ↗ |
| K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | Cogent Diagnotics , Ltd. | 1999-08-24 | Traditional | PDF ↗ |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | Elias U.S.A., Inc. | 1995-04-17 | Traditional | PDF ↗ |
Product code MLE · Class II · Immunology. Data: openFDA.