Panels › Immunology › Product code MLE · Class 2
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Regulation 866.5110
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MLE
| Company | 510(k)s | Recalls |
|---|---|---|
| Cogent Diagnotics , Ltd. | 1 | 0 |
| Elias U.S.A., Inc. | 1 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2001 | K010558 | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA Inova Diagnostics, Inc. | MLE |
| Aug 24, 1999 | K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA Cogent Diagnotics , Ltd., GB | MLE |
| Apr 17, 1995 | K951206 | VARELISA PARIETAL CELL ANTIBODIES Elias U.S.A., Inc. | MLE |
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