510(k) K013018 ยท MID System, Test, Anticardiolipin Immunological
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Sep 20, 2001 |
| Received | Sep 7, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013018
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.