510(k) K010558 ยท MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 3, 2001 |
| Received | Feb 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010558
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.